Assembly and method of implanting a heart assist system

ABSTRACT

A needle guard is used when suturing the cuff of an attachment ring to the heart. The needle guard is disposed in the attachment ring to prevent other parts of the attachment ring from being punctured by a suturing needle. The needle guard can include one or more grooves to inhibit relative movement between the needle guard and the attachment ring during suturing. The needle guard is removed upon completion of suturing and to allow insertion into attachment ring of an inflow conduit of a heart assist device. An articulated clamp is used to compress the attachment ring into engagement with the inflow conduit. The attachment include an annular rib that grabs the inflow conduit.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional Application No.61/487,660 filed May 18, 2011, which is incorporated herein byreference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to the field of heart assist devices and methods,devices and systems for the in vivo implantation of VADs and itsattachment to the heart.

2. Description of the Related Art

Heart assist devices are implantable devices that assist the heart incirculating blood in the body. A ventricular assist device (VAD) is anexample of a heart assist device that is used to assist one or bothventricles of the heart to circulate blood. For patients suffering fromheart failure, assisting the left ventricle with a VAD is more common.Currently, VADs are commonly used as a treatment option or a bridge totransplant for patients with heart failure.

The procedure to implant VADs carries many risks and side effects. Theimplantation procedure is invasive as surgeons need to access the heartdirectly by opening the chest with a sternotomy or a thoracotomy.Generally, a heart-lung bypass machine is used during the procedure, buta beating heart procedure may minimize side effects associated withusing a heart-lung bypass machine in such a major invasive surgery.However, a beating heart procedure can potentially lead to significantblood loss during the process of implanting the VAD if great care is notexercised.

While procedural related issues during the implantation process candirectly impact the success of the implantation, some of theseprocedural issues may also impact patients' recovery. When complicationsarise during the implantation process, the recovery time for these veryill patients can be extended. Procedural issues may result in majordetrimental side effects for patients, directly increasing the recoverytime. The recovery time and risk factors are often compounded by theoriginally poor health of the heart failure patient in need of the VAD.

A system and method for implanting a ventricular assist device without asternotomy is desired. Furthermore, a system and method for safelyimplanting a VAD without requiring heart-lung bypass is desired.Additionally, a system and method for implanting a ventricular assistdevice in a beating-heart procedure is desired.

SUMMARY OF THE INVENTION

Briefly and in general terms, the present invention is directed to aneedle guard, assembly, and method.

In aspects of the present invention, a needle guard comprises a cylinderand a stop member at the top end of the cylinder. The cylinder includesa top end, a bottom end surface, and cylindrical side surface definingan outer diameter. The stop member has a maximum width greater than theouter diameter of the cylindrical side surface.

In other aspects, the needle guard further comprises a handle at the topend of cylinder.

In other aspects, the handle comprises a stem and a pull member widerthan the stem. The stem disposed between the pull member and thecylinder.

In other aspects, the cylindrical side surface includes a first groovethat extends circumferentially around the cylinder.

In other aspects, the cylindrical side surface includes a second groovethat extends circumferentially around the cylinder. The first groovelocated axially between the second groove and the bottom end surface.

In other aspects, the second groove is adjacent the stop member.

In aspects of the present invention, an assembly comprises an attachmentring and a needle guard. The attachment ring has a ring channelextending through the attachment ring, the attachment ring including acylindrical ring wall and a cuff extending radially outward from thecylindrical ring wall, the cylindrical ring wall extendingcircumferentially around the ring channel. The needle guard includes acylinder shaped and sized to pass through the ring channel.

In other aspects, the cylinder has a maximum outer diameter that is thesame or about the same as an inner diameter of the cylindrical ringwall.

In other aspects, an axial length of the cylinder is the same or aboutthe same as a maximum axial length of the ring channel.

In other aspects, an axial length of the cylinder is greater than amaximum axial length of the ring channel.

In other aspects, the cylindrical ring wall includes a protrusion thatextends radially inward into the ring channel. The protrusion located ona central segment of the cylindrical ring wall.

In other aspects, the cylinder of the needle guard includes a groovethat extends circumferentially around the cylinder.

In other aspects, the attachment ring includes a ring seal configured toengage the groove.

In other aspects, the cylinder of the needle guard includes anothergroove that extends circumferentially around the cylinder.

In aspects of the present invention, a method comprises inserting aneedle guard into an attachment ring, inserting a suture through hearttissue and a cuff of the attachment ring while the needle guard istemporarily disposed within the attachment ring, the suture connectingthe attachment ring to the heart tissue.

In other aspects, the inserting of the needle guard includes abutting astop member of the needle guard against a top end of the attachmentring.

In other aspects, the inserting of the needle guard includes aligning agroove on a cylindrical side surface of the needle guard with a ringseal of the attachment ring.

In other aspects, the inserting of the suture is performed while abottom tip of the needle guard is located below an outer surface of theheart tissue.

In other aspects, the method further comprises removing the needle guardout of the attachment ring after the inserting of the suture.

In other aspects, the inserting of the suture includes passing a needleinto the heart tissue at a point located radially outward from the cuff,the needle connected to the suture, followed by passing the needle outfrom the heart tissue at a point located directly beneath the cuff,followed by passing the needle up through the cuff so that the suture ispulled through the heart tissue and the cuff.

Briefly and in general terms, the present invention is directed to aring clamp for securing an inflow conduit to an attachment ring. Inaspects of the present invention, a ring clamp comprises a first curved,a second curved piece, a third curved piece, and a lever. The firstcurved piece includes a first end, a second end, and a first engagementmember at the second end. The second curved piece includes a first endand a second end, the first end of the second curved piece pivotallyconnected to the first end of the first curved piece. The third curvedpiece includes first end, a second end, and a second engagement memberat the second end, the second engagement member configured toselectively engage and disengage the first engagement member. The leverincludes a first lever end, a second lever end, and a medial segment,the first lever end pivotally connected to the first end of the thirdcurved piece, the medial segment pivotally connected to the second endof the second curved piece.

In other aspects, the first engagement member is a hook and the secondengagement member is a catch.

In other aspects, the first curved piece, the second curved piece, orthe third curved piece includes a compliance feature configured tocircumferentially expand under tension and autonomously contract afterexpansion.

In other aspects, the compliance feature includes a series of curvedsegments configured to bend when tension is applied to opposite ends ofthe compliance feature.

In other aspects, the compliance feature includes an undulating wallhaving a wall thickness less than that of adjacent portions of thecurved piece including the compliance feature.

In other aspects, the compliance feature is formed of a material havingan elasticity that differs from the material of adjacent portions of thecurved piece including the compliance feature.

In other aspects, the third curved piece includes a groove.

In other aspects, the lever fits within the groove.

In other aspects, the ring clamp has a closed orientation in which thelever is disposed in the groove, the second engagement member is engagedto the first engagement member, and the first curved piece, the secondcurved piece, and the third curved piece complete a circular ring havingan inner diameter.

In other aspects, the ring clamp has a closed orientation in which thesecond lever end is disposed adjacent the first engagement member, thesecond engagement member is engaged to the first engagement member, andthe first curved piece, the second curved piece, and the third curvedpiece complete a circular ring having an inner diameter.

In other aspects, the second curved piece includes two leg membersattached to the medial segment of the lever, and the lever is sized tofit between the two leg members.

In other aspects, the lever and the third curved piece include detentfeatures configured to engaged each other.

In other aspects, at least one of the detent features is disposed on acantilevered member on the third curved piece.

In aspects of the present invention, a ring clamp a lever and aplurality of curved pieces, the lever and the curved pieces pivotallyconnected to each other, at least one of the curve pieces including acompliance feature configured to expand under tension and autonomouslycontract after expansion, wherein the lever is pivotally attached to twoof the curved pieces, the plurality of curved pieces includes a firstcurved piece, a second curved piece, and a third curved piece, andwherein the first curved piece is configured to selectively engage anddisengage the third curved piece.

In other aspects, the lever is pivotally attached to the second curvedpiece and to the third curved piece.

In other aspects, the third curved piece includes a groove configured toreceive the lever.

In other aspects, the compliance feature includes a series of curvedsegments configured to bend when tension is applied to opposite ends ofthe compliance feature.

In other aspects, the compliance feature includes an undulating wallhaving a wall thickness less than that of adjacent portions of thecurved piece including the compliance feature.

In other aspects, the compliance feature is formed of a material havingan elasticity that differs from the material of adjacent portions of thecurved piece including the compliance feature.

The features and advantages of the invention will be more readilyunderstood from the following detailed description which should be readin conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 illustrates a variation of the ventricular assist system.

FIGS. 2 a and 2 b are perspective and sectional views of a variation ofthe attachment ring attached to the valvular structure.

FIG. 3 a is a perspective view of a variation of the attachment ring.

FIG. 3 b is a cross-sectional view of A-A of FIG. 3 a.

FIG. 4 a is a perspective view of a variation of the attachment ring.

FIG. 4 b is a cross-sectional view of FIG. 4 a.

FIG. 5 illustrates a variation of the clamp.

FIGS. 6 a and 6 b illustrate a variation of the clamp in opened andclosed configurations, respectively.

FIGS. 7 a and 7 b illustrate a variation of the clamp on the attachmentring with the clamp in opened and closed configurations, respectively.

FIG. 8 a illustrates a variation of the attachment ring attached to theinflow conduit.

FIG. 8 b is a perspective view of section B-B of FIG. 8 a.

FIG. 8 c is the variation of cross-section B-B of FIG. 8 a shown in FIG.8 b.

FIG. 9 a illustrates a variation of the attachment ring attached to theinflow conduit.

FIG. 9 b is a perspective view of section B′-B′ of FIG. 9 a.

FIG. 9 c is the variation of cross-section B′-B′ of FIG. 9 a shown inFIG. 9 b.

FIGS. 10 a and 10 b are a perspective views of a variation of thevalvular structure.

FIGS. 10 c-10 e are perspective views of a variation of section C-C.

FIGS. 11 a through 11 c are bottom perspective, top perspective, and topviews, respectively, of a variation of the valvular structure.

FIGS. 12 a and 12 b illustrate perspective and section views,respectively, of a variation of the valve in a closed configuration.

FIG. 12 c is a perspective view of the valve of FIGS. 12 a and 12 b inan open configuration.

FIGS. 13 a and 13 b are top perspective and bottom perspective views ofa variation of the valve in a closed configuration.

FIGS. 13 c and 13 d are top perspective views of the valve of FIGS. 13 aand 13 b in open configurations.

FIGS. 14 a and 14 b are top perspective and bottom perspective views ofa variation of the valve.

FIGS. 15 a and 15 b are top perspective and bottom perspective views ofa variation of the valve.

FIGS. 15 c through 15 e illustrate variations of miter valves.

FIG. 15 f illustrates a variation of a duckbill diaphragm valve.

FIGS. 16 a and 16 b illustrate open and closed configurations,respectively, of a variation of the valvular structure of section C-C.

FIGS. 17 a and 17 b illustrate open and closed configurations,respectively, of a variation of the valvular structure of section C-C.

FIGS. 18 a and 18 b are exploded and top views of a variation of thevalve.

FIGS. 19 a and 19 b are perspective and sectional views of a variationof the valve integrated with an attachment ring.

FIGS. 19 c and 19 d are perspective and sectional views of a variationof the valve integrated with an attachment ring.

FIG. 20 illustrates a variation of the attachment ring and an explodedview of a variation of the valvular structure.

FIG. 21 a is a top perspective view of a variation of the valve.

FIG. 21 b is a variation of cross-section D-D of the valve.

FIG. 21 c is a bottom perspective view of the valve of FIG. 21 a withthe diaphragm flap shown in see-through.

FIG. 22 is a sectional view of a variation of the valvular structure.

FIG. 23 illustrates a variation of the valvular structure with thehousing shown in see-through.

FIG. 24 illustrates a variation of the valvular structure with thehousing in see-through.

FIG. 25 is a sectional view of a variation of a method for attaching thevalvular structure to the attachment ring.

FIGS. 26 a and 26 b are sectional views of a variation of a method forattaching the valvular structure to the attachment ring.

FIGS. 27 a and 27 b illustrate a variation of the method process flowfor implanting a variation of the ventricular assist system.

FIGS. 28 a and 28 b illustrate variations of a method for accessing thetarget site.

FIG. 29 a illustrates a variation of the tunneler.

FIGS. 29 b and 29 c illustrate variations of the tunneler of FIG. 29 awith the bullet tip removed.

FIG. 30 a illustrates a variation of the tunneler.

FIG. 30 b illustrates the tunneler of FIG. 30 a with the outer sheathremoved from the tunneler shaft.

FIG. 31 illustrates a variation of the tunneler attached to the outflowconduit.

FIG. 32 illustrates a variation of inserting the outflow conduit in thetarget site.

FIG. 33 a through 33 c illustrate a variation of a method foranastomosing the aorta to the outflow conduit.

FIG. 34 a illustrates blood flow through the outflow conduit afteraortic anastomosis.

FIGS. 34 b through 34 d illustrate variations of methods for stanchingblood flow through the outflow conduit.

FIG. 35 illustrates a variation of a method of attaching the attachmentring to the apex of the heart.

FIGS. 36 a and 36 c are perspective and side views, respectively, of avariation of the coring knife.

FIGS. 36 b and 36 d are perspective and side views of a variation ofsection F-F of FIG. 36 a.

FIG. 36 e is a side view of a variation of section F-F of FIG. 36 a withthe coring blade in a retracted configuration.

FIGS. 37 a and 37 b are perspective and sectional views, respectively,of a variation of the coring knife.

FIGS. 37 c and 37 d are front views of the coring knife with the coringabutment in a rotated configuration, and the coring blade in an extendedconfiguration, respectively.

FIG. 38 illustrates a variation of the coring knife.

FIGS. 39 a is a side view with the valvular structure shown in cut-away,of a variation of a method of using the coring knife with the valvularstructure.

FIG. 39 b is a perspective end view of FIG. 39 a.

FIGS. 40 a through 40 i illustrate a variation of a method for using avariation of the ventricular assist device system.

FIGS. 41 a through 41 d illustrate a variation of a method for coring.

FIGS. 42 a through 42 c illustrate a variation of inserting the inflowconduit through the attachment ring.

FIGS. 43 a and 43 b illustrate a variation of a method for stanchingblood flow through the pump outflow elbow and de-airing the pump.

FIG. 44 illustrates a variation of a method for de-airing theventricular assist device.

FIG. 45 illustrates a variation of attaching the pump to the outflowconduit.

FIGS. 46 a-46 d show an attachment ring, FIGS. 46 b and 46 d beingpartial cross-sectional sectional views.

FIGS. 47 a-47 c show an attachment ring, FIG. 47 a showing a flat sheetof material used for making the attachment ring.

FIGS. 48 a-48 d show an embodiment an attachment ring with an integralvalve.

FIGS. 49 a-49 d are perspective views of a clamp for use on anattachment ring, FIG. 49 d showing clamp closed on an attachment ring.

FIGS. 50 a and 50 b are plan and perspective views of a clamp for use onan attachment ring, showing ratcheting teeth for locking the clampclosed.

FIGS. 51 is a plan view of a clamp for use on an attaching ring with onepair of teeth.

FIGS. 52 a-52 c are perspective and cross-sectional views of a slittingtool for making a linear incision in the heart, the linear incisionallow for a subsequent circular incision.

FIGS. 53 a-53 f are perspective and partial plan views of a coring knifefor making a circular incision in the heart.

FIG. 54 is a partial plan view of a portion of a coring knife, showing avariation on the coring knife casing.

FIG. 55 is a partial plan view of a portion of a coring knife, showing avariation on the coring knife abutment.

FIGS. 56 a-56 d are perspective and proximal plan views of a valvularstructure having a spring-loaded hinge.

FIGS. 57 a-57 d are perspective and plan views of a valvular structurehaving two identical halves, FIGS. 57 c and 57 d showing view of thedistal end.

FIGS. 58 a-58 e are perspective, plan and side views of a C clamp forengaging a valvular structure onto an attachment ring.

FIGS. 59 a and 59 b are perspective views showing the C-clamp with anattachment ring and valvular structure.

FIGS. 60 a-60 b show an attachment ring, FIGS. 60 a being a half sectionview and FIG. 60 b being a partial sectional view.

FIGS. 61 a-61 d are perspective views of a clamp for use on anattachment ring.

FIGS. 62 a-62 c are perspective views of a clamp for use on anattachment ring, showing a compliance feature on the clamp.

FIGS. 63 a-63 c and 64 a-64 b show a needle guard and method of usingthe needle guard.

FIG. 65 shows a needle guard with grooves.

DETAILED DESCRIPTION

As used herein, any term of approximation such as, without limitation,near, about, approximately, substantially, essentially and the like meanthat the word or phrase modified by the term of approximation need notbe exactly that which is written but may vary from that writtendescription to some extent. The extent to which the description may varywill depend on how great a change can be instituted and have one ofordinary skill in the art recognize the modified version as still havingthe properties, characteristics and capabilities of the modified word orphrase. For example without limitation, something that is described as“substantially circular” in shape refers to a shape that is perfectlycircular and a shape that one skilled in the art would readily recognizeas being circular even though diameters measured at multiple locationson the circle are not exactly the same. As another non-limiting example,a first structure that is described as “substantially parallel” inreference to a second structure encompasses an orientation that isperfectly parallel and an orientation that one skilled in the art wouldreadily recognize as being parallel even though distances betweencorresponding locations on the two respective structures are not exactlythe same. In general, but with the preceding discussion in mind, anumerical value herein that is modified by a word of approximation mayvary from the stated value by ±15%, unless expressly stated otherwise.

Variations of a system and method for implanting a VAD during abeating-heart procedure are disclosed. The system can minimize orprevent blood loss from the heart during the system implantationprocedure, notably during the steps of coring a portion of theepicardial wall and insertion of the inflow conduit through theepicardial wall. The system can provide a fluid-tight seal around thesurgical tools used to access or come into contact with the internalfluid volume of the heart. Throughout this disclosure, one shouldappreciate that references made to VADs equally applies to all heartassist devices. Similarly, the system and surgical tools may apply to asimilar procedure of cannulation to other parts of the heart or of thecardiovascular system.

FIG. 1 illustrates a ventricular assist device (VAD) system 13 with apump 8. All locations described as proximal or distal, herein, arerelative to the location of the pump 8. The pump 8 can draw blood fromthe left ventricle, and deliver the blood to the aorta at a higherpressure to assist the pumping of the heart. The pump 8 is configured todirect blood flow from one location (e.g., the heart) to a secondlocation (e.g., target vasculature like an aorta) in the vascular systemto provide mechanical circulatory support/assistance. For example, thepump 8 can be configured as a unidirectional turbine pump 8 to directblood from the inflow side of the pump 8 (e.g., from the heart) to theoutflow side of the pump 8 (e.g., to the aorta). A percutaneous lead 5having insulated wires can be used for transmission and/or receiving ofdata and/or power between the pump 8 and a controller and/or a remotedevice for controlling the operation of the pump 8. In one variation, acontroller or remote is outside of the patient's body. The pump 8 canhave any configuration including but not limited to having axial flow orcentrifugal flow.

The pump 8 can be directly attached to or have an inflow conduit 10 at afirst end of the pump 8 and directly attached to or have an outflowconduit 2 at a second end of the pump 8. The inflow conduit 10 can becoupled with the pump 8 by a helically threaded coupler configured toattach to the inflow port 7 of the pump 8.

The inflow conduit 10 can have a hollow channel for fluid communicationsuch as directing blood from a first location (e.g., the heart) to thepump 8. In one variation, the inflow conduit 10 can be flexible. Inanother variation, the inflow conduit 10 can be rigid, such as a metaltube. In yet another variation, the inflow conduit 10 may have acombination of rigid and flexible elements such as having a proximal(relative to the pump 8) rigid elbow for coupling with the pump 8 thatis connected to a flexible middle portion to accommodate for bending anda distal rigid portion (relative to the pump 8) for coupling with theheart. The inflow conduit may also be formed by a portion of the pumpbody.

As illustrated in FIG. 1, the inflow conduit 10 has a distal end thatcan be placed through the valvular structure 12 and the attachment ring22 before entering into the heart after implantation. A flexible middleportion of the inflow conduit 10 provides strain relief between thedistal end and the proximal end. The proximal end is coupled with thepump 8. Blood can enter the inflow conduit 10 through its distalopening, travel along the length of the inflow conduit 10, and enter thepump 8 at the inflow port 7 of the pump 8 after exiting the proximalopening of the inflow conduit 10. The inflow conduit 10 can be integralwith, or separate and attachable to, the pump 8.

The valvular structure 12 is configured to prevent or minimize bloodloss from the heart during the implantation of the VAD. The valvularstructure 12 can be removed from the system and the patient once theinflow conduit 10 is properly positioned relative to the heart, forexample, after the inflow conduit 10 has been inserted into theattachment ring 22. The valvular structure 12 can seal against a coringknife and/or the inflow conduit 10 which passes through a channelthrough the valvular structure 12. The valvular structure 12 canminimize or prevent blood flow out from the heart during theimplantation of the VAD. Additionally the valvular structure 12 canprovide for passage of other instruments during the procedure whilepreventing blood loss out of the heart.

The valvular structure 12 can be directly attached to an attachment ring22, for example, indirectly attaching the valvular structure 12 to theapex of the heart during use. The attachment ring 22 can be configuredto connect to a ventricle. The attachment ring 22 can fix and sealagainst the inflow conduit 10 once the VAD is implanted. The attachmentring 22 can be a ventricle or heart connector. The attachment ring 22can fixedly attach to the VAD to the wall of the heart. Thus, theattachment ring 22 is configured to be secured against the heart, and isalso configured to be secured against the inflow conduit 10.

An outflow conduit is coupled to the second end (e.g., outflow port) ofthe pump 8 where the blood or fluid exits the pump 8. In an axial flowpump arrangement, the outflow conduit 2 is approximately linear andopposite to the inflow conduit 10. Similar to the inflow conduit 10, aproximal end (relative to the pump 8) of the outflow conduit 2 iscoupled to the pump 8, whereas the distal end (relative to the pump 8)of the outflow conduit 2 is for coupling to a target vasculature (e.g.,aorta) where blood re-enters the circulatory system after exiting thepump 8.

Similar also to the inflow conduit 10, the proximal end of the outflowconduit 2 can be rigid for coupling to the pump 8. The middle portion ofthe outflow conduit 2 can be made from a flexible material for bendrelief. In one variation, the distal portion of the outflow conduit 2(relative to the pump 8) can be a flexible sealed graft that can be sewnonto a target vasculature (e.g., aorta) by way of an anastomosis, forblood to re-enter the circulatory system.

The ventricular assist system can have fluid communication between theinflow port 7, the inflow conduit 10, the pump 8, the outflow conduit 2and the outflow port. The components of the ventricular assist systemshown in FIG. 1, except for the valvular structure 12, can all orpartially be from a Heartmate II Left Ventricular Assist Device (fromThoratec Corporation, Pleasanton, Calif.).

FIGS. 2 a and 2 b illustrate a valvular structure 12. In conjunctionwith other components in a system, this valvular structure 12 helps toprevent or otherwise minimize blood loss out of the heart during theimplantation or cannulation procedure, for example, when an opening iscreated in the heart while the heart is beating, or when a heart-lungby-pass machine is not used. The valvular structure 12 has a housing 18that can be substantially cylindrical with a valve 16 and/or one or moreseals 17 coupled to the inside wall of the structure. The valve 16 canact as either a complete or a partial seal for the valvular structure12. The valve 16 can allow the flow of fluid or entry of an element in adistal direction and substantially impair or completely prevent the flowof fluid or entry of an element in a proximal direction. The housing 18and valve 16 can be configured to be attachable to and removable fromthe attachment ring 22. The housing 18 can be separatable and removablefrom the valve 16. The housing 18 can have an attachment ring channel 14around the inner circumference of the housing 18. The attachment ring 22can be positioned inside of the attachment ring channel 14 and at ornear one end of the housing 18. The attachment ring 22 and valvularstructure 12 can have longitudinal axes 187. The longitudinal axis ofthe attachment ring 22 and the longitudinal axis of the valvularstructure 12 can be co-axial.

A de-airing channel 15 can be configured through the wall of the housing18. In the process of cannulation or implantation, air can be introducedinto the valvular structure 12. Air entering the circulatory system cancause air embolism and can be harmful to a patient. The de-airingchannel 15 can be used for purging all the air from the valvularstructure 12 prior to insertion of the inflow conduit 10 into the heartthus preventing air from entering the circulatory system. In onevariation, suction can be applied to and/or a fluid such as salineand/or blood can be delivered through the de-airing channel 15 to removeair from the system before the system is completely assembled. Thede-airing channel 15 can place the environment radially external to thesurface of the housing 18 in fluid communication with the attachmentring channel 14.

FIGS. 3 a and 3 b illustrate an attachment ring 22. The attachment ring22 can be attached to the epicardial wall, for example, by suturesthrough the cuffs 19 and 21 and the epicardial wall. After being suturedto the heart, the cuffs 19 and 21 can provide at least mechanicalsupport on the heart wall for the attachment ring 22, which serves as ananchoring point for securing of the inflow conduit 10 after it has beeninserted into the heart for fluid (e.g., blood) communication. Theattachment ring 22 can have an attachment ring wall 29 that defines anattachment ring channel 14. The attachment ring channel 14 can be openat both ends. The inflow conduit 10 can be passed through the attachmentring channel 14, accessing the chamber inside the ventricle. Theattachment ring 22 can have a substantial or nominal height. Theattachment ring wall 29 can be made from a silicone molded body withABS, Delrin, or combinations thereof. The attachment ring 22 can havepolypropylene ring inserts (e.g., to provide circular structure tofacilitate tool and inflow conduit 10 insertion) and reinforcedpolyester mesh (e.g., to prevent tearing). The attachment ring wall 29can be sutured to the cuff 19 and/or 21. The cuff pad 20 can be madefrom PTFE felt, titanium, silicone, or combinations thereof. Theattachment ring 22 can be from about 5 mm to about 25 mm tall. Theattachment ring wall 29 can have a thickness from about 1 to about 3 mm(e.g., not including flanges). The diameter of the attachment ringchannel 14 can range from about 10 mm to about 25 mm.

The attachment ring wall 29 can have a distal band 31 extending radiallyfrom the attachment ring wall 29 at or near the distal terminus of theattachment ring wall 29. The distal band 31 can be integral with theattachment ring wall 29. The distal band 31 can attach to the distaland/or proximal cuff 21. The attachment ring wall 29 can have a proximalband 26 at or near the proximal terminus of the attachment ring wall 29to maintaining a substantially circular cross-section adjacent to wherethe inflow conduit 10 is inserted into the attachment ring channel 14.The proximal band 26 can be a rigid metal or plastic. The proximal band26 can structurally reinforce the proximal end of the attachment ringwall 29. The attachment ring wall 29 can be flexible or rigid. Theseproximal and distal bands 26 and 31 can be used as anchors, attachmentpoints, visual alignment indicators and/or locks to other structures,components, or tools used in the implantation process.

The attachment ring 22 can be attached to the heart by stitching,suturing, or stapling one or more regions on the cuff 19 and/or 21 ofthe attachment ring 22 to the heart. The attachment ring wall 29 isattached to the cuff 19 and/or 21 having an annular shape with a distalcuff 19 or sewing region and a proximal cuff 21 or sewing region. Forexample, the cuffs 19 and/or 21 can be attached to the attachment ring22 by sutures, thread, staples, brads, welding, adhesive, epoxy, orcombinations thereof. The cuffs 19 and 21 extend radially from theattachment ring wall 29 outward. The distal cuff 19 can extend radiallymore outward than the proximal cuff 21, for example, the proximal cuff21 can structurally support the distal cuff 19 and provide a thickerlayer through which sutures can be stitched. The distal cuff 19 and theproximal cuffs 21 can form the shape of cylindrical discs with hollowcenters (i.e., where the attachment ring wall 29 and attachment ringchannel 14 are located). The distal cuff 19 can be on the distal side ofthe distal band 31, and the proximal cuff 21 can be on the proximal sideof the distal band 31 and attached to the distal band 31 and/or theattachment ring wall 29. The distal and proximal cuffs 21 can bestacked. The distal cuff 19 can be attached to the proximal cuff 21, forexample, at the radially outer circumference of the proximal cuff 21.

The cuffs 19 and/or 21 can each have a cuff pad 20 through which thesutures can be passed. The cuff pads 20 can be made from a mesh orfabric material that can be configured to allow penetration by a typicalsurgical needle and suture. The material of the cuff pad 20 can bestrong enough such that the cuff 19 and/or 21 can be secured by suturesagainst the epicardial wall without easily tearing should a small forcebe exerted on the attachment ring 22 by accidentally tugging theattachment ring 22 away from the epicardial wall. The cuff pads 20 canbe flexible. The cuff pads 20 can be configured to affix to suturespassed through the cuff pads 20.

The cuffs 19 and/or 21 can have cuff frames 23 that maintain the planarshape of the cuffs. The cuff frames 23 can also prevent the suture fromtearing through the cuff pad 20 and radially exiting and detaching fromthe cuff The cuff frames 23 can be rigid circular bands attached to theexternal circumference of the cuff pads 20. The cuff frames 23 can bemetal and/or hard plastic. The suture can be passed through the cuff pad20 radially inside of the cuff frame 23.

The attachment ring wall 29 can have a ring wall interface lip 25 thatcan prevent the clamp 24 from shifting, slipping, or otherwise comingoff the attachment ring wall 29. The ring wall interface lip 25 canextend radially from the attachment ring wall 29 proximal from the cuffs19 and 21.

An integral or separately attached clamp 24 can be on the attachmentring wall 29 distal to ring wall interface lip 25 and proximal to thecuffs 19 and/or 21. The clamp 24 can apply an inward radial forceagainst the attachment ring wall 29. The clamp 24 can exert acompressive radially force around the attachment ring wall 29, forexample, to pressure-fit the inner surface of the attachment ring wall29 to the outer surface of an inflow conduit 10 when the inflow conduit10 is passed through the attachment ring channel 14. The compressiveforce from the clamp 24 can hold and seal the attachment ring 22 againstthe inflow conduit 10. The attachment ring seal 34 can prevent bloodflow from the heart from exiting between the attachment ring 22 and theinflow conduit 10. The inflow conduit 10 can separately seal around thecored hole in the epicardium. The clamp 24 can be on the radial outsideof the attachment ring wall 29 between the ring wall interface lip 25and the cuffs.

FIGS. 4 a and 4 b illustrate that the attachment ring 22 can have anattachment ring seal 34 at the proximal end of the attachment ring wall29. The attachment ring seal 34 can extend radially inward from theattachment ring wall 29 into the attachment ring channel 14. Theattachment ring seal 34 can be flexible. The attachment ring seal 34(and any other seals disclosed herein) can be made from a soft,resilient elastomer or other polymer. The attachment ring seal 34 can beintegral with or separate and attached to the attachment ring wall 29.The attachment ring seal 34 can produce a fluid-tight seal againstelements placed in the attachment ring channel 14, when the element inthe attachment ring channel 14 has an outer diameter larger than theinner diameter of the attachment ring seal 34.

The proximal band 26 can be inside of the ring wall interface lip 25.The ring wall interface lip 25 can extend radially outward from theattachment ring wall 29. The ring wall interface lip 25 can interferencefit against the clamp 24 to prevent the clamp 24 from translatingproximally off the attachment ring wall 29. The ring wall interface lip25 can be attached to and/or abutted against by an element adjacent tothe attachment ring 22. For example, the inflow conduit 10 can abutagainst the ring wall interface to prevent the inflow conduit 10 frompassing too far through the attachment ring channel 14. Also forexample, the valvular structure 12 can attach to the ring wall interfacelip 25. The proximal band 26 also provides structural support and ahemostatic seal when the attachment ring wall interface lip 25 andvalvular structure housing 18 are joined together.

The attachment ring 22 can have one cuff 35. The attachment ring wall 29can have a first distal band 32 on a distal side of the cuff 35 and asecond distal band 33 on a proximal side of the cuff 35. The cuff 35 canbe attached to, or pressure fit between, the first distal band 32 andthe second distal band 33.

FIG. 5 illustrates that the clamp 24 can be made of a single, continuouswire of material. The clamp 24 can be made from a metal and/or polymer(e.g., plastic). The clamp 24 can have a clamp frame 37 to transmit theradially compressive force and clamp handles 36 that can be used to openand/or close the clamp frame 37. The clamp frame 37 can be resilientlydeformable. The clamp frame 37 can have a clamp diameter 38. When theclamp 24 is in a substantially or completely relaxed or unbiasedconfiguration, the clamp diameter 38 can be smaller than the outerdiameter of the attachment ring wall 29 to which the clamp 24 attaches.

The clamp handles 36 can extend radially from the remainder of the clampframe 37. Compressive, squeezing force can be applied to the oppositeclamp handles 36 to move the clamp handles 36 toward each other. Thecompressive force applied to the clamp handles 36 can expand the clampdiameter 38, placing the clamp 24 in an open configuration.

When the clamp 24 is in an open configuration, the clamp 24 can beloaded onto and/or removed from the attachment ring 22. In the openconfiguration, an inflow conduit 10 can be passed through or retractedfrom the attachment ring channel 14.

FIGS. 6 a and 6 b illustrate another variation of the clamp 24. FIG. 6 aillustrates the clamp 24 in an open configuration. The clamp 24 can havea frame made from a band of ribbon with a clamp handle 36 to loosen ortighten the clamp 24. The configuration as shown illustrates that afirst end of the clamp lever 39 is rotatably attached to a firstterminus of the clamp frame 37 and with the second end of the clamplever 39 rotatably attached to the clamp handle 36. The clamp handle 36can be rotatably attached to the second terminus of the clamp frame 37that is not attached to the clamp lever 39. The clamp handle 36 can beattached to the clamp frame 37 at a clamp hinge 40.

FIG. 6 b illustrates the clamp 24 in a closed configuration. In thisillustration, the clamp handle 36 is rotated to cause the clamp frame 37to tighten the clamp frame 37 in the closed configuration. The clamphandle 36 can lie flush against the outer circumference of a length ofthe clamp frame 37. The clamp lever 39 can position a first terminus ofthe clamp frame 37 toward the second terminus of the clamp frame 37 whenthe clamp handle 36 is closed.

The clamp diameter 38 can be smaller when the handle is closed than whenthe handle is open. When the handle is closed, the clamp diameter 38 canbe smaller than the outer diameter of the attachment ring wall 29 towhich the clamp 24 attaches. When the handle is open (as shown in FIG. 6a), the clamp diameter 38 can be larger than the outer diameter of theattachment ring wall 29 to which the clamp 24 attaches. When the handleis open, the clamp diameter 38 can be larger than the outer diameter ofthe ring wall interface lip 25.

FIG. 7 a illustrates that the clamp 24 can be on the attachment ring 22in an open configuration over the attachment ring external wall 29. Withthe clamp 24 in an open configuration, elements such as a coring knife,inflow conduit 10 or other surgical tools, can pass through theattachment ring channel 14. The clamp 24 can be against the outersurface of the attachment ring wall 29 between the ring wall interfacelip 25 and the cuff 35.

FIG. 7 b illustrates that the clamp 24 can be in a closed configurationover the attachment ring external wall 29. With the clamp 24 in a closedconfiguration, the attachment ring wall 29 can compress onto and sealagainst elements placed in the attachment ring channel 14, such as theinflow conduit 10. The clamp 24 can be between the second distal band 33and the ring wall interface lip 25. The clamp 24 can exert a radiallyinward force against the attachment ring wall 29. The closed clamp 24can reduce the diameter of the attachment ring wall 29 and the diameterof the attachment ring channel 14.

FIGS. 8 a through 8 c illustrate that the inflow conduit 10 can beinserted into the attachment ring 22 to access the heart with the inflowconduit 10 and route blood through an inflow conduit channel 178 fromthe heart to the pump 8. The inflow conduit 10 can have an inflowconduit stop 42 configured to abut against or attach to other elements,for example, to preventing the inflow conduit 10 from over-insertionthrough the attachment ring 22. The inflow conduit 10 distal to theinflow conduit stop 42 can have an outer diameter smaller than the innerdiameter of the attachment ring channel 14. The inflow conduit stop 42can have an outer diameter larger than the inner diameter of theattachment ring channel 14.

The clamp 24 can be biased open (e.g., by compressing the clamp handles36 toward each other) when the inflow conduit 10 is inserted into theattachment ring channel 14, for example, to allow the inflow conduit 10to pass freely through the attachment ring channel 14. The clamp 24 canbe released and returned to a compressive state around the attachmentring wall 29 when the inflow conduit 10 is in a desired location withinthe attachment ring 22, for example, to clamp 24 the attachment ring 22onto the inflow conduit 10 and hold the inflow conduit 10 in place.

FIGS. 9 a through 9 c illustrate that the variation of the clamp 24 ofFIGS. 6 a and 6 b can be in an open configuration when the inflowconduit 10 is inserted into the attachment ring channel 14, allowing theinflow conduit 10 to be inserted freely through the attachment ring 22.The clamp handle 36 can be rotated open.

The inflow conduit 10 can be advanced through the attachment ringchannel 14 until the inflow conduit stop 42 abuts the proximal end ofthe attachment ring wall 29, for example at the ring wall interface lip25. The inflow conduit 10 can extend out of the distal end of theattachment ring 22, for example into and within fluid communication withthe chamber of the heart.

When the inflow conduit 10 is in a desired location within theattachment ring 22, the clamp 24 can be closed or released, for example,compressing the attachment ring wall 29 onto the inflow conduit 10. Theinflow conduit 10 can then pressure fit against the inner surface of theattachment ring wall 29, for example holding the inflow conduit 10 inplace relative to the attachment ring 22.

FIGS. 10 a through 10 e illustrate a variation of the valvular structure12 that can have a clamshell housing 18. The valvular structure 12 canhave a housing 18 with a housing first portion 46 separatably attachedto a housing second portion 54. The housing first portion 46 can have arotatable clamshell attachment to the housing second portion 54 and canbe rotated open and removed from the remainder of the ventricular assistsystem. In a closed configuration, the housing portions 46 and 54 candefine a housing channel 58 longitudinally through the housing 18 andopen on each end. The housing first portion 46 can attach to the housingsecond portion 54 at a housing first seam 51 and a housing second seam48. The housing first seam 51 can have a housing first joint 50. Thehousing second seam 48 can have a housing second joint 49.

The housing joints 49 and 50 can be pinned hinges. For example, thefirst and/or second housing joints 49 and/or 50 can have first and/orsecond joint pins 52 and/or 53, respectively. The housing portions 46and 54 can rotate about the housing joints 49 and 50. The respectivepins 52 and 53 can be removed from the housing joints 49 and 50 and thehousing portions 46 and 54 can be separated from each other at thehousing joint 49 and 50. After separation, the housing portions 46 and54 can be reassembled at the housing joints 49 and 50 and the joint pins52 and 53 can be reinserted into the housing joints 49 and 50. When thehousing 18 is separated at one or both joints 49 and 50, the valve 16,which is a discrete and separate element from the housing 18, can comeout of the housing 18 or otherwise be removed or detached from thehousing 18.

One or both of the housing portions 46 and 54 can have de-airing ports62. The de-airing ports 62 can be the ends of the de-airing channels 15.Air can be suctioned out of the de-airing ports 62 and/or saline orblood can be delivered from inside the housing 18 through the de-airingports 62 to remove the air from the volume between the valve 16 and theheart wall during the de-airing process.

The valve 16 can have first, second, third, and fourth valve leaflets56. The leaflets 56 can be flexible and resilient. The leaflets 56 canbe made from an elastomer. The valve 16 can have inter-leaflet seams 64between adjacent leaflets 56. Each leaflet 56 can have an intra-leafletfold 66. Each leaflet 56 can have a leaflet rib 57 or reinforcement onthe inter-leaflet seam 64 or intra-leaflet fold 66, for example toreinforce the leaflet 56 at the seam 64 or fold 66. The leaflets 56 canallow fluids and solids to move in the distal direction through thehousing channel 58. The leaflets 56 can oppose fluids and solids movingin the proximal direction through the housing channel 58. The leaflets56 can close against pressure from the distal side of the leaflets 56,for example, preventing the flow of blood from the heart out of thevalvular structure 12.

The valve 16 can have a valve seal 60 proximal to the leaflets 56. Thevalve seal 60 can extend radially into the housing channel 58. The valveseal 60 can be resilient. The valve seal 60 can seal against an element,such as the coring knife or inflow conduit 10, located in the housingchannel 58. When the leaflets 56 are spread open, the valve seal 60between the seal and the coring knife or inflow conduit 10 can preventthe flow of blood from the heart past the valve seal 60 and out of thevalvular structure 12.

The housing 18 can have a housing seal 47 distal to the valve 16. Thehousing seal 47 can seat in, and attach to the housing 18, via acircumferential housing seal groove 55 in the housing 18. The housingseal 47 can extend radially into the housing channel 58. The housingseal 47 can be resilient. Similar to the valve seal 60, the housing seal47 can seal against an element, such as the coring knife or inflowconduit 10, located in the housing channel 58. When the leaflets 56 arespread open, the seal between the housing seal 47 and the coring knifeor inflow conduit 10 can prevent the flow of blood from the heart outpast the housing seal 47.

The valve 16 can have a valve shoulder 59 that extends radially from thebase of the valve leaflets 56. The valve shoulder 59 can seat andinterference fit into a valve groove 61 recessed in the inner surface ofthe housing 18. The valve shoulder 59 can hold the valve 16 in the valvegroove 61.

FIGS. 11 a through 11 c illustrate another variation of the valvularstructure 12 that can have a latching closure configuration. The housing18 of this variation of the valvular structure 12 can latch closed, asshown in FIGS. 2 a and 2 b, locking the housing first portion 46 to thehousing second portion 54 in a closed configuration. The housing 18 canalso be opened by unlatching the housing first portion 46 to the housingsecond portion 54.

The housing 18 can have a first joint that can have a first joint latch69. The joint latch can be rotated open (as shown), decoupling thehousing first portion 46 and the housing second portion 54 at thehousing first seam 51. The first joint latch 69 can be rotated closed,laying substantially flush with the outer wall of the housing 18. In aclosed configuration, the first joint latch 69 can be closed onto andattach to a first joint catch 70. The first joint latch 69 can be on thehousing second portion 54, the first joint catch 70 can be on thehousing first portion 46.

When the housing first portion 46 is separated from the housing secondportion 54, the housing 18 can be removed from the valve 16. The valve16 is destructible and can be torn away from the ventricular assiststructure by hand or with a knife and removed from the target site afterthe housing 18 is removed. For example, after the inflow conduit 10 isinserted through the attachment ring 22 and the housing 18 is removed,the valve 16 can be torn away from the inflow conduit 10.

The housing first portion 46 and/or housing second portion 54 can eachhave coupling grooves 71 proximal to the valve 16. The coupling grooves71 can be configured to slidably and lockably interface with radiallyextending locking tabs 181 on other components that can interact withthe housing 18 such as the slitting blade case 158, coring knife, inflowconduit 10, or combinations thereof. The locking tabs 181 and couplegroove can interface to hold, fix, or otherwise releasably couple thecomponent inserted through the housing 18 to the housing 18 and to alignthe component inserted through the housing 18 to the housing 18. Forexample, the locking tabs 181 and coupling groove 71 can cause a slitfrom a slitting blade case 158 to be at the same angular orientation andposition as a coring abutment disc later-inserted through the slit, asshown in FIGS. 40 b and 40 c.

FIGS. 12 a through 15 b illustrate variations of the valve 16 withdifferent configurations. FIGS. 12 a and 12 b illustrate that the valve16 shown in FIGS. 10 a through 10 e can be a four-leaflet valve 16. Theinter-leaflet seams 64 can extend radially from the center of the valve16 to the valve shoulder 59 with no inter-leaflet seam extending throughthe valve shoulder 59 or through the valve shoulder 59 to the outercircumference of the valve 16, or combinations thereof. For example, asshown in FIG. 12 c, one of the inter-leaflet seams 64 can extend throughthe valve shoulder 59 while the remainder of the inter-leaflet seams 64can extend to the valve shoulder 59 without extending through the valveshoulder 59, and the one inter-leaflet seam 64 that extends through thevalve shoulder 59 can be aligned with one of the housing seams 51 or 48when loaded in the housing 18.

The inter-leaflet seams 64 can be completely separated seams,perforations, or combinations thereof along the length of the seam(e.g., complete separation between the leaflets 56 and perforation asthe seam extends through the valve shoulder 59). The valve 16 can betearable by hand, for example along the inter-leaflet seam 64. Forvalves 16 with a completely separated inter-leaflet seam 64, no tearingis necessary to separate the valve 16 from an element which the valve 16surrounds, such as the inflow conduit 10. As shown in FIG. 12 c, thevalve can be rotated open, as shown by arrows, in a clamshellconfiguration to release the valve 16 from an inner element or componentwhich the valve 16 surrounds.

FIGS. 13 a through 13 c show another variation of the valve 16. Thevalve 16 can be a quadcuspid (i.e., four-leaflet) valve that can haveinter-leaflet seams 64 that can extend through the valve shoulder 59 tothe outer circumference of the valve 16. FIG. 13 c illustrates that thevalve 16 can be rotated open, as shown by arrows, at a firstinterleaflet seam 64 that extends through the valve shoulder 59 betweenthe first leaflet 68 and the second leaflet 65. The oppositeinter-leaflet seam 64 can extend to, but not through the valve shoulder59, acting as a hinge around which the valve halves can rotate. FIG. 13Dillustrates that the remaining inter-leaflet seams 64—other than theinter-leaflet seam 64 that extends through the valve shoulder 59 betweenthe first leaflet 68 and second leaflet 65—can extend to but not throughthe valve shoulder 59. The valve 16 can be further rotated open tospread open each inter-leaflet seam 64, for example when removing thevalve 16 from the coring tool or inflow conduit 10 placed through thevalve 16.

FIGS. 14 a and 14 b illustrate yet another variation of the valve 16that can be a tricuspid valve (i.e., having three leaflets). FIGS. 15 aand 15 b illustrate yet another variation of the valve 16 that can be abicuspid valve (i.e., having two leaflets).

FIGS. 15 c through 15 e illustrate variations of the valve 16 that canhave opposite inter-leaflet seams 64 that extend through the shoulder ona first side of the valve 16, and not through the shoulder on a secondside of the valve 16, opposite to the first side of the valve 16. Theopposite inter-leaflet seams 64 can converge in the middle of the valve16 to form a single slit along a diameter of the valve 16. The valves 16can be miter valves. The leaflets can join together at miters or bevelsat the inter-leaflet seams 64. The leaflets can pucker or duckbill atthe inter-leaflet seams 64.

FIG. 15 c illustrates a quadcuspid valve 16. FIG. 15 d illustrates abicuspid valve 16. FIG. 15 e illustrates a unicuspid valve 16 (i.e.,having one leaflet) that can have a seam that does not extend to thevalve shoulder. A unicuspid valve is a type of diaphragm valve. Adiaphragm valve can have no more than one seam extending to theshoulder. The seam can be similar in length to the diaphragm seam 88shown in FIGS. 21 a and 21 b.

FIG. 15 f illustrates a diaphragm valve 16 that can have a diaphragm 82but no leaflets. The seam in the valve 16 can be a straight slit or port83 that can be closed in a relaxed an unbiased configuration. The slitor port 83 can extend along a diameter of the valve 16, but not extendto the valve shoulder 59. The valve 16 can duckbill, pucker or miteraround the port 83.

FIGS. 16 a and 16 b illustrate a variation of the valvular structure 12that can have a valve 16 that can be an inflatable membrane 73. Thevalve 16 can be inflated and deflated to close and open, respectively,the valve 16. The valve 16 can have an inflatable valvular chamber 75between the inflatable membrane 73 and the housing 18. The inflatablemembrane 73 can be resilient. The inflatable membrane 73 can be in adeflated and open configuration, as shown in FIG. 16 a.

FIG. 16 b illustrates that the inflatable membrane 73 can be in aninflated and closed configuration. The inflatable valvular chamber 75can be pressurized, as shown by arrows, with a liquid (e.g., saline) orgas (e.g., carbon dioxide) to inflate the inflatable membrane 73. Theinflatable membrane 73 can seal around elements in the housing channel58, such as the coring knife or inflow conduit 10. The inflatablemembrane 73 can have a high-friction surface facing the housing channel58 that can pressure-fit against the coring knife or inflow conduit 10,fixing the coring knife or inflow conduit 10 in the housing channel 58.Alternatively, the inflatable membrane 73 can have a low-frictionsurface facing the housing channel 58 that can allow the coring knife ofinflow conduit 10 to slide within the housing channel 58 against theinflated inflatable membrane 73.

The pressure in the inflatable valvular chamber 75 can be released,returning the inflatable membrane 73 to the open configuration andreleasing the pressure-fit against any elements in the housing channel58.

FIG. 17 a illustrates a variation of the valvular structure 12 that canhave a valve 16 that can be a torsioning or twisting membrane 77. Thetop and bottom of the housing 18 can be counter-rotated to open or closethe twisting membrane 77. The twisting membrane 77 can be loose andnon-resilient or taught and resilient and elastic. The housing firstportion 46 and second portion can each have a top rotatably attached toa bottom. The twisting membrane 77 can be attached to housing tops 78(the housing first potion top is shown) and bottoms 79 (the housingfirst potion bottom is shown) by a membrane anchor ring 76. The twistingmembrane 77 can be in an untwisted and open configuration, as shown.

FIG. 17 b illustrates that the housing tops 78 can be rotated withrespect to the housing bottoms 79, as shown by arrows, for example, topartially or completely close the valve 16. The twisting membrane 77 cantwist upon itself and around elements in the housing channel 58. Thetwisting membrane 77 can be in a twisted and closed configuration. Thetops and bottoms can be counter-rotated to untwist and open the twistingmembrane 77.

FIGS. 18 a and 18 b illustrate another variation of the valve 16 thatcan be a diaphragm valve that can be closed in an unbiased configurationand stretched open when the inflow conduit 10 or coring knife is pushedthrough the diaphragm valve. The valve 16 can have a first diaphragm 80and a second diaphragm 86. The diaphragms can be made from resilientmaterial, such as an elastomer, or combinations thereof. For example,the diaphragm can be made from silicone, polyurethane or other bloodcompatible polymers. The first diaphragm 80 can be in contact with andattached to the second diaphragm 86.

The first diaphragm 80 can have a first diaphragm port 81 that canreceive the inflow conduit 10 or coring knife. The second diaphragm 86can have a second diaphragm port 85 that can also receive the inflowconduit 10 or coring knife. The diaphragm ports can be circular. Thediaphragm ports can be resiliently expandable. For example, when a solidelement, such as the inflow conduit 10 or coring knife, with a diameterlarger than the diaphragm ports is forced through the diaphragm portsthe diaphragm ports can expand in shape and size to allow the solidelement to pass through the ports and can seal against the solidelement. When the solid element is removed from the diaphragm ports, thediaphragm ports can return to the relaxed, unbiased, shape and size ofthe diaphragm port.

The first diaphragm 80 can have a diaphragm interface lip 84. Thediaphragm interface lip 84 can be used to hold to diaphragm in the valvegroove 61 in the housing 18. The diaphragm interface lip 84 can be aring around the outer circumference of the first diaphragm 80 that canbe raised or thickened compared to the remainder of the first diaphragm80. The diaphragm interface lip 84 can be formed a result of theattachment of the second diaphragm 86 and the first diaphragm 80. Forexample the diaphragm interface lip 84 can be a rib formed by fusing,gluing or welding, or a reinforcement.

The second diaphragm 86 can have a diameter smaller than the diameter ofthe first diaphragm 80. The second diaphragm 86 can be attached to thefirst diaphragm 80 at or near the outer circumference of the seconddiaphragm 86. The second diaphragm 86 can attach to the first diaphragm80 on the diaphragm interface lip 84 or on the face of the firstdiaphragm 80 on the opposite side of the diaphragm interface lip 84.

When the first diaphragm 80 and the second diaphragm 86 are attached,the first diaphragm port 81 can be incongruous from (i.e., notoverlapping with) the second diaphragm port 85 when the first and seconddiaphragms 80 and 86 are in relaxed, unbiased configurations. When thediaphragm valve 16 is in a relaxed, unbiased configuration, the firstdiaphragm port 81 and the second diaphragm port 85 can overlapcompletely, partially or not at all (as shown). The diaphragm valve 16can have a substantially fluid-tight seal in a relaxed configuration.

The diaphragm valve 16, or other valve variations such as the leafletvalves, can allow a check flow, for example a small amount of blood flowused to test or confirm if positive blood pressure exists on theopposite side of the valve 16. For example, the pressure between thefirst diaphragm 80 and the second diaphragm 86 can be insufficient tocompletely seal when pressurized blood from the heart is in contact withthe diaphragm valve 16, and a small trickle or drip-flow of blood canpass through the diaphragm ports 81 and 85. In an alternative variation,the leaflets can have a check flow channel, a small channellongitudinally aligned in the inter-leaflet seam that can allow checkflow to flow between adjacent leaflets in a direction opposite to thelow-resistance orientation of valve.

FIGS. 19 a and 19 b illustrate a variation of the attachment ring 22with an integrated diaphragm valve 16. The first diaphragm 80 can beintegral with the attachment ring wall 29. The first diaphragm 80 cansubstantially close the end of the of the attachment ring channel 14.The second diaphragm 86 can be attached to the first diaphragm 80 and/orthe attachment ring wall 29. Similarly, the other valve types describedcan also be integrated with the attachment ring 22. For example, FIGS.19 c and 19 d illustrates a variation of the attachment ring 22integrated with a quadcuspid valve 16. FIG. 20 illustrates the explodedassembly of a variation of the diaphragm valve 16 in a valvularstructure 12 attached to an attachment ring 22. The valve 16 can beseparate and detachable from the attachment ring 22. The diaphragm 82can be attached to a diaphragm flap 87. The housing first portion 46 andhousing second portion 54 can have a diaphragm groove 90circumferentially around the radially inner surface of the housing 18.The diaphragm interface lip 84 can seat in and attach to the diaphragmgroove 90.

The housing first portion 46 and housing second portion 54 can have aring groove 94 circumferentially around the radially inner surface ofthe housing 18. The ring wall interface lip 25 can seat in and attach tothe ring groove 94.

The housing first portion 46 can have a housing first handle 93. Thehousing second portion 54 can have a housing second handle 91. Thehousing handles 91 and 93 can be pulled to separate the housing firstportion 46 from the housing second portion 54. For example, the housingfirst seam 51 and the housing second seam 48 can be completely separatedor perforated.

The tape 89 can be a substantially unresilient, flexible polymer striptightly wrapped around the radial outer surface of the housing 18. Thetape 89 can radially compress the housing first portion 46 and thehousing second portion 54, keeping the housing first portion 46 attachedto the housing second portion 54. The tape 89 can have an adhesiveapplied to the radial inner surface. The tape 89 can be wound once ormore around the housing 18 and can stick to the housing 18 and to innerlayers of the tape 89 itself

Alternatively, the tape 89 can be an elastomeric hollow cylinder orband. The tape 89 can be placed onto the housing 18 by stretching thetape 89 over the housing 18 and releasing the tape 89 from thestretching force, resiliently radially compressing the housing 18.

FIGS. 21 a through 21 c illustrate another variation of the diaphragmvalve 16. FIG. 21 b illustrates that the diaphragm 82 can have adiaphragm seam 88 extending from the diaphragm port 83 to the externalcircumference of the diaphragm 82. The diaphragm seam 88 can be acomplete split separating each side of the diaphragm seam 88, allowingan element, such as the inflow conduit 10 or coring knife, to passthrough the diaphragm 82 at the diaphragm port 83 and/or the diaphragmseam 88. The diaphragm port 83 can be in the radial center of thediaphragm 82. The diaphragm flap 87 can cover the diaphragm port 83.

FIG. 21 c illustrates that the diaphragm flap 87 can attach to thediaphragm 82 at an attachment area 96. The diaphragm flap 87 can beunattached to the diaphragm 82 except for at the attachment area 96,allowing the diaphragm flap 87 to open out of the way when an element ispushed through the diaphragm port 83 and/or diaphragm seam 88. Thediaphragm flap 87 can be rigid or flexible. The diaphragm flap 87 can beresilient. The diaphragm flap 87 can be made from the same materials asthe diaphragm 82.

The diaphragm flap 87 can extend to the external circumference. Thediaphragm flap 87 can cover the diaphragm port 83 and the diaphragm seam88. The diaphragm flap 87 can cover a portion of the side of thediaphragm 82 and leave a portion of the side of the diaphragm 82 exposed(as shown) or can cover the entire side of the diaphragm 82.

When the fluid pressure on the side of the diaphragm 82 of the diaphragmflap 87 exceeds the fluid pressure on the side of the diaphragm 82opposite the diaphragm flap 87, the diaphragm flap 87 can press againstthe diaphragm seam 88 and diaphragm port 83, further sealing thediaphragm 82.

When an element, such as the coring knife or inflow conduit 10, isforced through the diaphragm 82 from the side of the diaphragm 82opposite of the diaphragm flap 87, the element can press open thediaphragm 82 at the diaphragm port 83 and diaphragm seam 88, and thediaphragm flap 87 can be pressed aside as the element moves through thediaphragm 82.

FIG. 22 illustrates that when the valvular structure 12 is assembled thediaphragm interface lip 84 can be seated in the diaphragm groove 90 ofthe housing 18. The housing first portion (not shown) and the housingsecond portion 54 can be compressed together by tape 89 wound around theexternal circumference of the housing 18.

FIG. 23 illustrates that the valvular structure 12 can have a lockingring 98 that can be used to compress the attachment ring 22 against aninflow conduit 10 placed in the attachment ring channel 14. For example,the locking ring 98 can be used in lieu of or in addition to the clamp24. The locking ring 98 can be releasably attached to the radiallyinternal surface of the housing 18. The locking ring 98 can be separablyattached to the housing 18 with circumferential rails and interfacinggrooves on the radially outer surface of the locking ring 98 and theradially inner surface of the housing 18.

The de-airing ports 62 (as shown) can act as handle ports and/or be usedto de-air the valvular structure 12. The handle ports can attach tohousing handles or can be open to be used for de-airing, as describedherein.

FIG. 24 illustrates that the tape 89 can be wound radially around theouter surface of the housing 18. The tape 89 can compress the housingfirst portion 46 to the housing second portion 54. The tape 89 can haveadhesive, for example, on the side of the tape 89 facing the housing 18.The tape 89 can have no adhesive and be elastic, for example, attachingto the outer surface of the housing 18 by a friction-fit from the tape89 elastically compressing against the housing 18.

FIG. 25 illustrates that the valvular structure 12 can be attached tothe attachment ring 22, for example, by snapping the valvular structure12 onto the attachment ring 22. The valvular structure 12 can beattached to the attachment ring 22 before or during the VAD implantprocedure.

The valvular structure 12 can be translated, as shown by arrow, over theattachment ring wall 29. The ring wall interface lip 25 can have asloped side facing in the direction of the on-loading valvular structure12. As the valvular structure 12 is being pressed onto the attachmentring 22, the portion of the housing 18 that is distal to the ring groove94 can deform over the sloped side of the ring wall interface lip 25.The ring wall interface lip 25 can then seat and interference fit intothe ring groove 94.

FIGS. 26 a and 26 b illustrate another variation of snapping thevalvular structure 12 onto the attachment ring 22. In this variation,the valvular structure 12 can have a locking ring 98. The locking ring98 can have a locking ring wall angle 100 with respect to the housingchannel longitudinal axis 103. The locking ring wall angle 100 can be,for example, from about 3° to about 15°, for example about 10°.

The ring wall interface lip 25 can have a sloped side facing in thedirection of the on-loading valvular structure 12. The sloped side ofthe ring wall interface lip 25 can form a ring wall angle 102 with theattachment ring channel longitudinal axis 101. The ring wall angle 102can be from about 3° to about 15°, for example about 10°. The ring wallangle 102 can be substantially equal to the locking ring wall angle 100.

The valvular structure 12 can be pressed onto the attachment ring 22,over the attachment ring wall 29, as shown by arrow. As the valvularstructure 12 is being pressed onto the attachment ring 22, the portionof the housing 18 distal to the ring groove 94 can deform over thesloped side of the ring wall interface lip 25.

FIG. 26 b illustrates that the valvular structure 12 can be pressed ontothe assembly ring, as shown. The ring wall interface lip 25 can seat andinterference fit into the ring groove 94.

Method of Using

FIGS. 27 a and 27 b illustrate a process for surgically implanting aventricular assist system. It should be appreciated to a person withordinary skills in the art that the surgical, preparation, andimplantation processes described can be performed in a different orderas presented. The surgical process for implanting the ventricular assistsystem can begin by anesthetizing the patient and placing the patient ina supine position. The left ventricular apex and ascending aorta 104 canthen be exposed using a less invasive approach, such as a left subcostalincision and a second right anterior mini-thoracotomy, or a commonsternotomy which is typically more invasive but allows more space for asurgeon to operate.

The method can include space for placement of an outflow conduit 2/graftby tunneling from a subcostal position to an aortic location. Forexample, an outflow graft tunnel can be created between the twoincisions (e.g., the left subcostal incision and the right anteriormini-thoracotomy) with a malleable tunneler and/or a curved tunneler.The tunneler 177 can begin at the left subcostal thoracotomy and tunnelto the right anterior mini-thoracotomy.

The tunneler 177 can have a tunneler tip that can then be removed fromthe tunneler once the tunneler has reached the right anteriormini-thoracotomy. The outflow graft connector can then be attached tothe end of the tunneler and pulled back through the tunnel createdbetween the incisions. The outflow graft can then be connected to a pumpsizer at the target site for the pump 8. The pump sizer is a plasticelement the size and shape or the pump 8 that can be used to check thefit of the finally deployed pump 8 by inserting the pump sizer at thetarget site before inserting the pump 8.

With the outflow graft attached to the pump sizer, the outflow graft canbe measured and cut to length to fit the space between the pump 8 andthe aorta 104 with enough slack in the outflow conduit 2 to allowmovement of the pump 8 and organs, but not too much slack to enablekinking of the outflow conduit 2.

If the process does not include the use of a heart-lung by-pass machineand is performed while the heart 106 is pumping, the outflow graft canthen be anastomosed to the aorta 104 using a side biting clamp to holdthe aorta 104 and an aortic punch 126 to make the incision in the aorta104.

After blood is allowed to flow into the outflow graft for purging airfrom inside the outflow graft or conduit 2, a clamp 131, such as ahemostat, can then be placed on the outflow graft 2, or a balloon 135can be inflated in the outflow graft to stanch the flow of blood fromthe aorta 104 through the outflow graft 2. The control of blood from theheart 106 and de-airing can also or additionally be performed bycreating a slit into the wall of the outflow graft 2. A balloon catheter132 can then be delivered into the outflow graft 2 through the slit. Theballoon 135 can then be positioned in the pump outflow connector andinflated to plug the pump outflow connector. End and or side ports onthe balloon catheter 132 can be used for de-airing.

The pump 8 and the inflow conduit 10 or inflow graft can be preparedprior to connection of the inflow conduit 10 to the heart 106. Theproximal end of the inflow conduit 10 is connected to the pump 8 in asaline bath to purge all air from the inflow conduit 10 and the pump 8prior to having the distal end of the inflow conduit 10 connected to theheart 106. In this preparation process, the entire inflow conduit 10 andthe pump 8 can both be submerged into a saline bath and connected. Ablockage at the outflow end of the pump 8 is placed to prevent bloodfrom escaping after the distal end of the inflow conduit 10 is connectedto the heart 106.

Prior to connection of the inflow conduit 10 to the heart 106, theattachment ring 22 can be sewed onto the epicardial surface of thetarget connection area on the heart 106. In one variation, sutures canbe used to secure the cuff 35 of the attachment ring 22 onto the heart106. The valvular structure 12 or external seal can then be securedagainst the attachment ring 22, for example, by placing and securing thevalvular structure 12 over the walls forming the attachment ring channel14. A slitting blade or tool can be inserted through the valvularstructure 12 and the attachment ring 22 to create a slit into themyocardium at the target connection area. A coring knife 140 can then beinserted through the slit and used to core a portion of the myocardium.The inflow conduit 10 can then be inserted through the valvularstructure 12 and the attachment ring 22 to into the opening of the heart106 created by the coring knife. The inflow conduit 10 can be secured tothe attachment ring 22 with the radial clamp 24. The valvular structure12 including the external seal can then be removed. The inflow conduit10 can be inserted further into the left ventricle. The radial clamp 24can then be radially compressed (e.g., released from a radially expandedconfiguration) and/or locked to secure the inflow conduit 10 to theattachment ring 22.

The entire system can be completely de-aired in the process ofconnecting the outflow graft to the pump 8. De-airing or the removal ofall the air from the outflow graft and the pump 8 can be performed withthe use of a de-airing bladder, enclosure or a bath of saline. Theunconnected end of the outflow graft can be submerged into the bath ofsaline along with the outflow end of the pump 8 that has the blockage.The clamp or balloon 135 can be removed from the outflow graft and allthe air in the outflow graft and pump 8 can be allowed to escape orpushed by the flow of blood from the aorta 104 into the bladder,enclosure, or the bath of saline, for de-airing. Similarly, the outflowend of the pump 8 with the blockage is also submerged into the salinebath. Once the hemostatic outflow graft clamp 131 is removed from theoutflow graft and the blockage is removed from the outflow end of thepump 8, any air remaining in either the outflow graft or in the pump 8will be allowed to escape into the saline bath or enclosure. If theballoon 135 had previously been inserted into the pump outflowconnector, the de-airing can occur by releasing the hemostatic clamp 131from the outflow graft 2 resulting in blood from the aorta 104 floodingand bleeding out the outflow graft 2. The outflow graft 2 can then beconnected to the pump outflow connector. The balloon 135 can be deflatedand the balloon catheter 132 can then be pulled out from outflow graft2. The hole in the site of the outflow graft 2 used for introducing theballoon catheter 132 can then be closed with a purse string suture. Theoutflow graft 2 is connected to the outflow end of the pump 8 after airis removed from the system.

A tunnel can be formed for the percutaneous lead 5 to extend from thepump 8 out of the body. The pump 8 can then be turned on to run andassist the blood flow from the left ventricle. The surgical wounds onthe patient can then be closed.

FIGS. 28 to 35 will collectively illustrate the process of accessing theheart 106 and target implantation vasculature and the tools used tocreate a tunnel for an outflow conduit 2. FIGS. 28, 32 and 35 illustratethe process of creating a tunnel and implanting an outflow conduit 2 inthe tunnel, and FIGS. 29 a through 31 illustrate the variations of toolsused for this tunnel creation process. FIGS. 33 a through 33 cillustrate the process and tools for creating an aortotomy 128 in thetarget vasculature for an anastomotic connection with the outflowconduit 2. FIGS. 34 a through 34 b illustrate the processes and toolsfor preventing blood from spilling out of the outflow conduit 2 after itis connected to the target vasculature.

FIG. 28 a illustrates the creation of a tunnel for the outflow conduit 2without a sternotomy. FIG. 28 b illustrates that when a sternotomy isperformed, creating a sternotomy opening 107, there is no need to tunnel

In a less invasive variation of the procedure, as shown in FIG. 28 a,the target site can be accessed by making a first incision 110 caudallyor inferior to the target site, for example just below the apex on theleft side of the heart 106. A second incision 108 can be made cranial tothe target site, on an opposite side of the target site from the firstincision 110. The second incision 108 can be made near the right secondintercostal to provide access to the aorta 104. The tunneler 177 canthen be inserted, as shown by arrow 111, into the first incision 110 andtunneled between the first and second incision 110 and 108, as shown byarrow 109. The end of the tunneler 177 can then exit, as shown by arrow105, from the patient at the second incision 108, or be inside thepatient but accessible from the second incision 108.

FIGS. 29 a to 30 b illustrate variations of a tunneler 177 that can beused for creating the outflow conduit tunnel FIG. 29 a illustrates oneexample of a tunneler 177 that can have an elongated tunneler shaft 115.The tunneler 177 can have a tunneler handle 114 at a proximal end of thetunneler shaft 115. The tunneler shaft 115 can be straight when in atorsionally unstressed state. The tunneler shaft 115 is of asubstantially smaller diameter than the distal attachment cone 118 sothat it can be malleable or flexible for shaping into a configurationthat fits the anatomy of the patient. The tunneler 177 can have a distalattachment cone 118 at the distal end of the tunneler shaft 115. In onevariation, this distal attachment can be a bullet tip 124 at the distalend of the tunneler 177. The bullet tip 124 can have a smooth or flushseam with the distal attachment cone 118. The bullet tip 124 can beremoved from the distal attachment cone 118 and expose or be replacedwith different distal attachment interface configurations. For example,the bullet tip 124 can be attached to, or replaced with, a distalattachment collet 123 extending distally from the distal attachment cone118, as shown in FIG. 29 b. Similarly, the bullet tip 124 can beattached to, or replaced with, a distal attachment bolt 122 extendingdistally from the distal attachment cone 118, as shown in FIG. 29 c. Thedistal attachment bolt 122 can have helical thread 121. The objective ofthe distal attachment bolt 122 and the distal attachment collet 123 arefor attachment with a proximal end of the outflow graft as will beillustrated further below.

FIGS. 30 a and 30 b illustrate another variation of the tunneler 177that can have an outer sheath 125 attached to the distal attachment cone118. The tunneler shaft 115 can be separate from the outer sheath 125and distal attachment cone 118. The outer sheath 125 can be of adiameter that is similar to the diameter of the distal attachment cone118 and can be hollow. While the diameter of the tunneler shaft 115 andthe outer sheath 125 differs, the outer sheath 125 and the tunnelershaft 115 can have substantially equal radii of curvature. The tunnelershaft 115 and outer sheath 125 can be rigid. The tunneler shaft 115 canbe slidably received by the outer sheath 125.

The tunneler 177 can be inserted through the first incision 110 at adesired location in the abdomen and/or thorax to create the tunnel forultimate placement of the outflow conduit 2. The bullet tip 124 can beconfigured with a blunt tip to atraumatically separate or create a paththrough tissue when the tunneler 177 is being inserted through thepatient.

FIG. 31 illustrates that the bullet tip 124 can be removed and theoutflow conduit coupler 4 can be attached to the distal attachmentinterface. The outflow conduit 2 can extend from the terminus of thetunneler 177. The tunneler 177 can be used to manipulate the locationand orientation (i.e., rotate, twist, translate, steer) of the outflowconduit 2.

The outflow conduit 2 can be attached to the tunneler 177 after thedistal end of the tunneler 177 is passed through the patient and out of,or adjacent to, the second incision site, such as a surgical openingnear the aorta 104 like a right anterior mini thoracotomy or a ministernotomy near the aorta 104. FIG. 32 illustrates that when the distalattachment interface is positioned at the distal end of the tunnel orout of the second incision 108, the bullet tip 124 can be removed fromthe distal attachment interface and the outflow conduit coupler 4 can beattached to the distal attachment interface. The tunneler handle 114 canthen be pulled to draw the outflow conduit coupler 4 and outflow conduit2 through the tunnel

FIG. 33 a illustrates the use of an aortic clamp 127 to clamp a portionof the wall of the aorta 104. This aortic clamp 127 can be a side-bitingclamp of any shape, and is typically used when the vasculature (e.g.,aorta 104) is still filled with blood, for example, when a heart-lungby-pass machine is not used. An aortic punch 126, or scalpel or othertool can be applied to the clamped portion of the aorta 104 to create asmall opening in the vasculature or target vessel (e.g., aorta 104), asshown in FIG. 33 b. FIG. 33 c illustrates that the outflow conduit 2 canthen be attached to the target vessel by attaching the circumferentialedge of the distal end of the outflow graft/conduit around the openingwith sutures (as shown), staples, clips, brads, glue, or combinationsthereof.

FIG. 34 a illustrates removal of the aortic clamp 127 from the aorta104. Once the aortic clamp 127 is removed, blood flow 130 through theaorta 104 will branch off and flow through the outflow conduit 2, asshown by arrows. If the outflow conduit 2 is not obstructed, the bloodflow 130 from the aorta 104 can flow through the outflow conduit 2 andexit through the (proximal) open end of the outflow conduit 2.

FIG. 34 b illustrates a variation of a method for stanching the bloodflow 130 through the outflow conduit 2. A vascular clamp 131 can beplaced on the outflow conduit 2 to compress the outflow conduit 2,closing and obstructing the outflow conduit 2 and stanching the flow ofblood from the aorta 104 through the outflow conduit 2.

FIG. 34 c illustrates another variation of a method for stanching bloodflow 130 through the outflow conduit 2. An inflatable balloon 135,similar to an angioplasty balloon, can be inserted through the wall ofthe outflow conduit 2. The balloon 135 can be in fluid communicationwith a catheter 132. The balloon 135 can be inflated with a gas (e.g.,carbon dioxide) or liquid (e.g., saline.) The balloon 135 can beinflated when in the outflow conduit 2, closing the outflow conduit 2and stanching the flow of blood from the aorta 104 through the outflowconduit 2. The balloon 135 can be made of a single material along theentire surface of the balloon 135.

FIG. 34 d illustrates yet another variation of a method for stanchingblood flow 130 through the outflow conduit 2. The balloon 135 can becovered with two or more materials. In a first variation, the balloon135 can be a composite balloon made of two sub-balloons, the firstsub-balloon covered with a first material and having a first volume, andthe second sub-balloon covered with the second material and having asecond volume. In a second variation, the balloon 135 cave have a firstvolume covered by the first material and separated by a balloon septum185 from the second volume covered in the second material. The firstvolume can be in fluid communication with a first channel in thecatheter 132, and the second volume can be in fluid communication with asecond channel in the catheter 132 or a second catheter. The firstmaterial can be on the balloon distal surface 133 and the secondmaterial can be on the balloon proximal surface 134. The first materialon the balloon distal surface 133 can be gas impermeable. The secondmaterial on the balloon proximal surface 134 can be made from a materialthat can be gas permeable, but not liquid permeable (i.e., a breathablemembrane such as PTFE or acrylic copolymer). The balloon distal surface133 can face the aorta 104 and the balloon proximal surface 134 can faceaway from the aorta 104 when the balloon 135 is inserted in the outflowconduit 2 and inflated.

When de-airing the outflow conduit 2, fluid (e.g., blood and residualair) can be pumped from the pump 8 through the outflow conduit coupler4. Air in the VAD can pass through the balloon proximal surface 134 andinto the balloon 135. The balloon distal surface 133 and first volumecan be inflated to obstruct the air from flowing through the vessel andforce the air into the balloon proximal surface 134 while allowing theblood and/or saline to flow through the outflow conduit 2 and into theaorta 104. The air captured in the balloon 135 can be withdrawn throughthe catheter 132.

FIG. 35 illustrates that the outflow conduit 2 can be drawn through thetunnel, for example, positioning the outflow conduit coupler 4 near thefirst incision 110 or otherwise at or adjacent to the target site forthe pump 8. As described above, the outflow conduit 2 can be connectedto the aorta 104 (i.e., aortic anastomosis) with an aortic attachmentdevice, such as aortic sutures 117. The aortic anastomosis can occurbefore or after the outflow conduit 2 is drawn into and/or through thethorax, for example, by the tunneler 177.

After the outflow conduit 2 is drawn through the thorax, the attachmentring 22 can be sutured to the heart apex 119 with an apical attachmentdevice, such as apical sutures 113. The attachment ring 22 can be placedagainst, and attached to, either the left (e.g., at the apex) or rightventricles or the left or right atria. The apical sutures 113 can be thesame or different suture material and size as the aortic sutures 117.The attachment ring 22 can be attached to the apex with or without thevalvular structure 12 attached to the attachment ring 22.

FIGS. 36 a through 38 illustrate variations of a cutting tool, such asthe coring knife 140, that can be used to core a piece of the epicardialtissue while the heart 106 is beating. FIGS. 36 a through 36e illustratea variation of the coring knife 140 with a cylindrical coring blade 137configured to chop or shear heart tissue against an abutment surface onthe proximal side of a conical knife head 136. FIGS. 37 a through 37dillustrate another variation of the coring knife 140 that can have arotatable coring abutment 145 to insert through a small slit in theheart 106 and then rotate to squeeze against and compress the hearttissue which is desired to be cored. FIG. 38 illustrates a yet anothervariation of the coring knife 140 that has a foreblade 152 that isindependently deployable from the knife head 136.

FIGS. 36 a through 36d illustrate a variation of the coring knife 140.The coring knife 140 can have a hollow cylindrical coring blade 137. Thecoring knife 140 can have a conical or bullet-shaped knife head 136. Theknife head 136 can be shaped to push apart a pre-cut slit in epicardialtissue to introduce the knife head 136 into the left ventricle. Theproximal surface of the knife head 136 can be a coring abutment 145 thatthe coring blade 137 can cut against.

The coring knife 140 can have a knife handle 139 at the proximal end ofthe coring knife 140. The knife handle 139 can be fixed to a coringcontrol shaft 143. The coring control shaft 143 can be fixed to theknife head 136. Translation of the knife handle 139 can directly controltranslation of the knife head 136. The knife can have a knife stop 138radially extending from the body of the coring knife 140. The knife stop138 can limit the extent of the translation of the knife handle 139, andtherefore the knife head 136, with respect to the coring blade 137. Theknife stop 138 can prevent over insertion of the coring blade 137 intotissue. For example, in use the knife stop 138 can abut the attachmentring 22 or valvular structure housing 18 preventing or minimizing therisk of inserting the coring blade 137 through the heart wall and intothe septum.

FIG. 36 e illustrates that the knife handle 139 can be translateddistally, as shown by arrow, to translate the knife head 136 distally(i.e., extend), as shown by arrow, away from the coring blade 137. Theknife handle 139 can be translated proximally, as shown by arrow, totranslate the knife head 136 proximally (i.e., retract), as shown byarrow, toward the coring blade 137. The coring abutment 145 caninterference fit against the distal cutting edge of the coring blade137. The coring abutment 145 can move within and adjacent to the coringblade 137, for example when the outer diameter of the coring abutment145 is smaller than the inner diameter of the distal end of the coringblade 137. In this configuration, the coring abutment 145 can sheartissue against the coring blade 137.

FIGS. 37 a and 37 b illustrate a variation of the coring knife 140 thatcan have a rotatable coring abutment 145 that can be passed through aslit in the heart wall and then rotated to face the coring blade 137.The coring abutment 145 can be a circular disc. If the slit in the heartwall is not already created when the coring abutment 145 is passedthrough the heart wall and/or the slit is not large enough for thecoring abutment 145 to pass, the circular disc of the coring abutment145 can be used to create the slit in the heart wall. The coringabutment 145 can be rotatably attached to a control arm 146. The controlarm 146 can be attached to the knife handle 139 in a configurationallowing the knife handle 139 to rotate the coring abutment 145 throughmanipulation of the control arm 146. The knife handle 139 can berotatably attached to the proximal end of the coring control shaft 143.

The outside surface of the coring control shaft 143 can have a helicalcoring groove, for example along the length of the coring control shaft143 that passes through the coring knife case 141. The coring knife case141 can have a guide peg 148 that extends radially inward from thecoring knife case 141. The guide peg 148 can be fixed to the coringknife case 141. The guide peg 148 can seat in the helical coring groove,controlling the movement of the coring control shaft 143 with respect tothe coring knife case 141. For example, the coring blade 137 can berotated helically with respect to the coring knife case 141.

FIG. 37 c illustrates that the knife handle 139 can be rotated, as shownby arrow 142, rotating the coring abutment 145, as shown by arrow 149.The plane defined by the coring abutment 145 in a rotated configurationcan be parallel to the plane defined by the cutting edge of the coringblade 137.

FIG. 37 d illustrates that the knife handle 139 can be moved in ahelical motion, as shown by arrow 144, helically moving the coringcontrol shaft 143 and coring blade 137, as shown by arrow 150. Thehelical motion of the knife handle 139 can be constrained by the guidepeg 148 slidably fitting into the helical coring guide 147. The coringblade 137 can be helically rotated and translated to abut the proximalsurface of the coring abutment 145. The coring blade 137 can be rotatedand translated until the coring blade 137 abuts the coring abutment 145.

FIG. 38 illustrates that the coring knife 140 can have a foreblade 152that can be used to create a slit in the epicardial tissue through whichthe coring knife 140 can be inserted into the ventricle. The coringknife 140 with a rotatable coring abutment 145 can also be configuredwith an integral foreblade 152. The foreblade 152 can be controllablyextended distally out of the distal surface of the knife head 136. Thecoring knife 140 can have a foreblade control knob 155 that can be usedto extend and retract the foreblade 152. The foreblade control knob 155can be fixed to the foreblade 152 by a foreblade control shaft 174,shown in FIGS. 41 b through 41 d. The foreblade control knob 155 can betranslated proximally and distally, as shown by arrows 154, within aknob port 157 to translate the foreblade 152 proximally and distally,respectively, as shown by arrows 153, with respect to the knife head136.

Translating the knife handle 139, as shown by arrows 162, can translatethe knife head 136, as shown by arrows 151, independently of theforeblade 152. Translating the knife handle 139 can extend and retractthe coring blade 137. The foreblade control knob 155 can be rotated,shown by arrows 156, to lock or unlock the translation of the foreblade152 to the translation of the knife handle 139.

The knife head 136 can have a chisel-tipped configuration. The distalend of the knife head 136 can be traumatic or atraumatic.

FIGS. 39 a and 39 b illustrate that the coring knife 140 can beinserted, as shown by arrow, through the housing 18 of the valvularstructure 12 and the attachment ring 22. The leaflets 56 of the valve 16can resiliently deform away from the coring knife 140. The leaflets 56,valve seal 60, housing seal 47, or combinations thereof, can formfluid-tight seals around the coring knife 140, for example to prevent orminimize the flow of blood from the heart 106 and out of the valvularstructure 12 during use of the coring knife 140.

FIGS. 40 a through 40 i illustrate a variation of a method for coringthe heart 106 and attaching the inflow conduit 10 to the heart 106 whilethe heart 106 is beating. FIG. 40 a illustrates that the attachment ring22 can be placed against the wall of the heart 106. One or more sutures113 can be sewn through the cuff 35 and the heart 106, fixing theattachment ring 22 to the heart 106. The clamp 24 can be attached to theattachment ring 22 in an open configuration, as shown. The valvularstructure 12 can be attached to the attachment ring 22 before or afterthe attachment ring 22 is attached to the heart 106. The air can beremoved from the attachment ring channel 14 and/or housing channel 58 atany time by inserting blood and/or saline into the de-airing port 62and/or by applying suction to the de-airing port 62, for example beforeslitting or coring an opening into the heart wall.

FIG. 40 b illustrates that the initial slit in the heart wall can bemade by a slitting blade. The slitting blade can be contained in aslitting blade case 158 and configured to extend from and retract intothe slitting blade case 158. The slitting blade case 158 can be insertedthrough the valvular structure 12 and attachment ring 22. The slittingblade case 158 can have slitting blade handles 160 and a slitting bladeplunger 159. The slitting blade plunger 159 can control a sharp, linearslitting blade (not shown) at the distal end of the slitting blade case158. The slitting blade plunger 159 can be translated, as shown by arrow161, inserting the slitting blade through the heart 106 and forming aslit in the heart 106. The valve 16 and seals in the valvular structure12 can form a fluid-tight seal against the slitting blade case 158,preventing blood from flowing out of the heart 106 through the valvularstructure 12. The slitting blade case 158 can be removed from thevalvular structure 12 and the procedure site after the slit is formed.Instead of a slitting blade, the slit can be formed by a foreblade 152extended from a coring knife 140, as shown and described in FIGS. 41 athrough 41 d.

FIG. 40 c illustrates that the coring knife 140 can be translated, asshown by arrow 163, into the valvular structure 12 and attachment ring22. The coring knife 140 engages with the valvular structure 12 withlocking tabs 181 and locking slots or coupling grooves 71 to provide areliable connection and a depth marker and locator. The coring abutment145 can be inserted through the slit in the heart 106 formed by theslitting blade. The coring abutment 145 can be pushed into the leftventricle 165 while the heart 106 continues to beat. The seals and valve16 can produce a seal around the coring knife 140 preventing blood fromflowing out of the beating heart 106 through the valvular structure 12.

FIG. 40 d illustrates that the knife handle 139 can be rotated, as shownby arrow 142, rotating the coring abutment 145, as shown by arrow 149,for example, to prepare the coring knife 140 to core a portion of theheart 106. The coring abutment 145 can be in a plane substantiallyparallel with, and adjacent to, the internal side of the adjacent heartwall in the left ventricle 165.

FIG. 40 e illustrates twisting the coring blade 137 to cut a cylinder ofthe heart wall away from the rest of the heart wall. The handle can behelically moved, as shown by arrow 144, helically extending the coringblade 137, as shown by arrow 150, through the heart wall. The distaledge of the coring blade 137 can be sharpened and/or serrated and cancut the heart wall as the coring blade 137 moves through the heart wall.The coring abutment 145 can resist motion of the heart wall away fromthe coring blade 137, compressing the heart wall between the coringblade 137 and the coring abutment 145. The coring blade 137 can beextended until the coring blade 137 contacts the coring abutment 145,coring the heart wall. The heart wall can be cored coaxial (i.e., alongsubstantially the same longitudinal axis) with the valvular structure 12and/or attachment ring 22.

In an alternative variation of the coring knife 140 with the coringabutment 145 having a smaller outer diameter than the inner diameter ofthe cutting edge of the coring blade 137, the coring blade 137 can beextended until the coring blade 137 passes adjacent to the coringabutment 145, shearing the cored tissue 175 between the coring blade 137and the outer circumference of the coring abutment 145.

The coring knife 140 can be withdrawn and removed from the heart 106,attachment ring 22 and valvular structure 12 with the coring blade 137pressed against the coring abutment 145 to form a closed volume in thecoring blade 137. The core of heart tissue formed by the coring blade137 can be stored within the coring blade 137 and removed from thetarget site with the coring knife 140.

FIG. 40 f illustrates that the inflow conduit 10 of the pump 8 (pump 8not shown in FIG. 40 f) can be translated, as shown by arrow 183, intothe valvular structure 12 and the attachment ring 22. The inflow conduitstop 42 can abut and interference fit against the housing 18, stoppingtranslation of the inflow conduit 10.

The valvular structure 12 and attachment ring 22 can be de-aired byapplying suction to the de-airing port 62 of the valvular structure 12and/or injecting saline or blood into the de-airing port 62. Thevalvular structure 12 can be de-aired once during the implantation ofthe ventricular assist system or multiple times throughout theimplantation, for example immediately before and/or after insertion ofthe inflow conduit 10 through the valvular structure 12.

After the inflow port 7 of the inflow conduit 10 is located in the heart106 and/or past a fluid tight seal formed against the attachment ring 22(e.g., with the attachment ring seal 34) and/or the valvular structure12 (e.g., with the housing seal 47 and/or valve 16), the valvularstructure 12 can be removed from the attachment ring 22. For example,the first joint latch 69 can be opened, as shown by arrows 168. Thehousing first portion 46 and housing second portion 54 can then berotated open and removed from the attachment ring 22, as shown by arrows169.

FIG. 40 g illustrates the valvular structure 12 in a configuration whenbeing opened and in the process of being removed from the inflow conduit10. A first portion of the valvular structure 12 can be rotated awayfrom a second portion of the valvular structure 12. For example, theinter-leaflet seam 64 can open at a lateral perimeter surface of thevalve 16, splitting open the valve 16 along the respective housing seam51 or 49, and the housing first portion 46 can rotate open away from thehousing second portion 54 at a hinge at the housing second seam 48. Whenthe housing 18 is removed, the valve 16 can separate from the housing 18and remain on the inflow conduit 10. The valve 16 can then be rotatedopen at the end of an interleaf seam that extends to but not through thevalve shoulder 59 (with the valve shoulder 59 acting as a hinge), asshown in FIG. 40 g, and/or cut or torn at the interleaf seam and pulledaway from the inflow conduit 10. The valve 16 can be removed with thehousing 18 from the inflow conduit 10, as shown in FIG. 40 g, or afterthe housing 18 is removed from the inflow conduit 10. FIG. 40 hillustrates the inflow conduit 10 and attachment ring 22 following theremoval of the valvular structure 12. The pump 8 is not shown but isattached to the distal end of the inflow conduit 10. The inflow conduit10 can have an indicator that the pump 8 should be attached to thedistal end of the inflow conduit 10.

FIG. 40 i illustrates that the inflow conduit 10 can be furthertranslated, as shown by arrows, into the left ventricle 165. The inflowconduit 10 can be translated until the inflow conduit stop 42interference fits against the ring wall interference lip. The clamphandle 36 can then be closed, as shown by arrow 170, reducing thediameter of the clamp 24 and pressure fitting or compressing the insideof the attachment ring 22 against the outside of the inflow conduit 10,reducing or preventing translation of the inflow conduit 10 with respectto the attachment ring 22. The outside surface of the inflow conduit 10can form a fluid-tight seal against the inside surface of the attachmentring 22 for example at the attachment ring seal 34. The inflow conduit10 can be removed or repositioned, for example, by opening the clamphandle 36, removing or repositioning the inflow conduit 10, and thenclosing the clamp handle 36.

The heart 106 can pump blood during the creation of the slit, insertionof the coring abutment 145 into the ventricle, coring, insertion of theinflow conduit 10 into the heart 106, removal of the valvular structure12, tightening of the clamp 24 around the attachment ring 22, orcombinations or all of the above.

FIGS. 41 a through 41 d illustrate a method of coring a portion of theheart wall using a variation of the coring knife 140 similar to thevariation shown in FIG. 38. FIG. 41 a illustrates that the coring knife140 can be placed adjacent to a valvular structure 12 with a diaphragmvalve 16. FIG. 41 b illustrates that the coring knife 140 can beinserted through the diaphragm port 83. The diaphragm port canelastically deform to accommodate the coring knife 140 passing throughthe diaphragm port. The diaphragm can form a fluid-tight seal around thecoring knife 140 as the coring knife 140 is inserted into the diaphragmport. The foreblade 152 can be extended out of the distal end of theknife head 136 and pressed into the heart wall, as shown by arrow. Theforeblade 152 can cut or slit the heart 106. The knife head 136 can bepushed into the slit or cut in the heart wall made by the foreblade 152.

FIG. 41 c illustrates that the knife handle 139 can be translated towardthe heart 106, extending the knife head 136 into the left ventricle 165,as shown by arrow. The coring abutment 145 can be facing the innersurface of the heart wall. The foreblade 152 can be retracted to beatraumatically covered by the knife head 136.

FIG. 41 d illustrates that the knife handle 139 can be translated awayfrom the heart 106, retracting the knife head 136 toward the coringabutment 145, as shown by arrow. The coring abutment 145 and coringblade 137 can cut tissue away from the heart wall. The coring abutment145 and coring blade 137 can shear (if the coring abutment 145 has asmaller diameter than the diameter of the coring blade 137) or chop (ifthe coring abutment 145 has a diameter larger than or equal to thediameter of the coring blade 137) the tissue. Cored tissue 175 can bestored within the internal volume of the coring blade 137 until afterthe coring knife 140 is removed from the valvular structure 12. When thecoring knife 140 is removed from the valvular structure 12, thediaphragm can close, preventing or minimizing blood flow from the heart106 from exiting the valvular structure 12.

FIGS. 42 a through 42 c illustrate a method of using a valvularstructure 12 having a locking ring 98 to clamp the attachment ring 22 tothe inflow conduit 10. FIG. 42 a illustrates that the inflow conduit 10can be inserted, as shown by arrow, through the valvular structure 12having a diaphragm valve 16 (the diaphragm can be elastically deformedout of the way of the inflow conduit 10 but is not shown forillustrative purposes). The diaphragm port 83 can elastically expand toaccommodate the inflow conduit 10. The diaphragm port 83 can form afluid-tight seal around the inflow conduit 10, preventing blood fromflowing from the heart 106 out the valvular structure 12.

FIG. 42 b illustrates that the tape 89 can then be removed from thevalvular structure 12. The housing 18 can then be separated into thehousing first portion 46 and the housing second portion 54 componentsand removed from the target site. The diaphragm valve 16 can then beremoved, such as by being torn or cut away from the inflow conduit 10 orremoved with the housing 18 when the diaphragm seam 88 opens.

FIG. 42 c illustrates that the locking ring 98 can be forced toward theheart 106, as shown by arrow. In the configuration shown in FIG. 42 c,the locking ring 98 can compress the ring wall 29. The inner diameter ofthe ring wall 29 can be reduced by the compressive pressure from thelocking ring 98. The radially inner surface of the attachment ring wall29 can compress against and press-fit to the radially outer wall of theinflow conduit 10, forming a fluid-tight seal. The locking ring 98 canbe pulled away from the heart 106, relaxing and expanding the attachmentring wall 29, for example reducing the force of or completelyeliminating the press fit between the radially inner surface of theattachment ring wall 29 and the radially outer surface of the inflowconduit 10.

FIGS. 43 a and 43 b illustrate a variation of a method for de-airing theoutflow conduit 2. FIG. 43 a illustrates that when the blood flow in theoutflow conduit 2 is stanched by a clamp 131 (as shown) or balloon 135,a balloon catheter 132 can be inserted through the wall of the outflowconduit 2. The pump 8 can be de-aired, for example the pump 8 can be runwhen in fluid communication with the ventricle, or the pump 8 can bepre-loaded with saline or blood. The balloon 135 can then be insertedinto the terminal outflow end of the pump 8 and inflated, for examplemaintaining the pump 8 and inflow conduit 10 in a de-aired condition(i.e., with no air within the fluid channel of the pump 8 or the inflowconduit 10).

FIG. 43 b illustrates that the outflow conduit 2 can be joined to thepump 8 at the outflow conduit coupler 4. The clamp 131 can be removedfrom the outflow conduit 2 before coupling the outflow conduit 2 to thepump 8, allowing blood from the aorta 104 to de-air the outflow conduit2 and then the outflow conduit 2 can be joined to the pump 8.

Alternatively, the outflow conduit clamp 131 can remain on the outflowconduit 2 after the outflow conduit 2 is joined to the pump 8. Theballoon 135 can then be removed from the pump 8 and outflow conduit 2,and the pump 8 can be run. The air from the outflow conduit 2 betweenthe outflow conduit clamp 131 and the pump 8 can be forced out throughthe hole in the side wall of the outflow conduit 2 directly or drawn outvia a needle inserted into the outflow conduit 2. If a balloon catheterwith side ports is used, the catheter ports can be used to withdraw airinstead of using the hole in the graft or an additional needle.

Once the outflow conduit 2 and the remainder of the system is de-aired,the balloon 135 (as shown) and/or outflow conduit clamp 131 can beremoved from the outflow conduit 2. If a catheter 132 was removed fromthe wall of the outflow conduit 2, a suture can be sewn if needed, suchas by a purse stitch, into the outflow conduit 2 to close the hole inthe outflow conduit wall.

Alternatively, when the outflow conduit 2 is occluded by the balloon 135or clamp 131, the pump 8 can be attached to the outflow conduit 2 andoperated. Excess air in the ventricular assist system can be withdrawnwith a catheter 132 or the bi-material balloon described herein.

FIG. 44 illustrates another variation of a method for de-airing thesystem using a liquid-filled de-airing bladder, enclosure or pouch toprevent air from entering the VAD components during assembly of theoutflow conduit 2 and the pump 8. The outflow conduit coupler 4, outflowend of the pump 8 and the end of the outflow conduit 2 to be attached tothe pump 8 can be placed in the de-airing pouch 179. The de-airing pouch179 can be filled with saline before or after placing the VAD componentsin the de-airing pouch 179. The attachment ring 22 can be previouslyde-aired through the de-airing port 62 on the valvular structure 12. Theoutflow conduit 2 can be previously de-aired with blood flow from theaorta 104 and stanching, for example, with an outflow conduit clamp 131or balloon 135. The pump 8 and inflow conduit 10 can be pre-filled withsaline or blood before delivery into the target site. The outflow portof the pump 8 can be plugged before the pump 8 is delivered into thetarget site.

When the outflow end of the pump 8 and the inflow end of the conduit arelocated in the de-airing pouch 179, the balloon 135 in the outflowconduit 2 can be deflated and removed or the outflow conduit clamp 131on the outflow conduit 2 can be removed. The blood flowing from theaorta 104 can de-air the outflow conduit 2, purging air in the outflowconduit 2 into the de-airing pouch 179. The purged air can then escapefrom the de-airing pouch 179 or travel to a portion of the de-airingpouch 179 away from the openings of the VAD components. The pump 8 canbe driven to pump blood through the inflow conduit 10 and pump 8 todrain any additional air from the pump 8 and inflow conduit 10. Theoutflow conduit 2 can then be attached to the pump 8 in the de-airingpouch 179 or without a de-airing pouch 179, as shown in FIG. 43 b or 45.

The percutaneous lead 5 can be attached to the pump 8 and to externalpower, control and data transmission devices as known in the art.

The system can be implanted when the heart 106 is beating and thepatient is not on cardio-pulmonary bypass. However, the system can beimplanted with the patent on cardio-pulmonary bypass and the heart 106slowed or stopped. The system can be implanted using less invasivetechniques described herein, but can be implanted with a fullthoracotomy and sternotomy.

In FIGS. 46 a and 46 b, another embodiment of attachment ring 22 isformed by injection molding a polymer in a mold containing reinforcementelements which are to be imbedded or encased within the polymer. Themold cavity includes geometric features that simultaneously forminterface lip 25, cylindrical ring wall 29 which forms a tubular fluidpassageway, distal band 31, and ring seal 34 as a single, unitarystructure. Ring seal 34 forms the circular, inner edge of the proximalopening to ring channel 14.

Attachment ring 22 is flexible. The polymer used for molding can besilicone rubber, although other polymers suitable for implantation maybe used. When completely cooled and/or cured after molding, the polymeris flexible and elastic to allow ring seal 34 to flex, conform, and sealagainst a cylindrical object that is inserted through ring channel 14.The reinforcement elements include proximal reinforcement band 202,distal reinforcement band 204, and fiber mesh 206. Proximal and distalreinforcement bands 202, 204 can be made of a material that is morerigid than the polymer injected into the mold and which forms theremainder of attachment ring 22. The additional rigidity providedproximal and distal reinforcement bands 202, 204 help openings at theopposite ends of ring channel 14 maintain a circular shape. Proximal anddistal reinforcement bands 202, 204 can be made of Nylon, acetal,polycarbonate, HDPE, PP, PET, PEEK, titanium or stainless steel. Fibermesh 206 can be made of polyester fibers that have been braided to forma mesh tube which is then placed in the mold as part of the moldingprocess. Other types of fibers and mesh configurations can be used.Fiber mesh 206 can be distributed within distal band 31 and ring wall29. Fiber mesh 206 helps prevent the polymer from tearing due tomechanical stress, such as may be arise from sutures used later toattach cuff 35 to distal band 31. Flared ends of fiber mesh 206 providepositive fixation of sutures to the polymer substrate of distal band 31.

Attachment ring 22 can be rotationally symmetric about longitudinal axis200, so that interface lip 25, ring wall 29, distal band 31, ring seal34, proximal reinforcement band 200, and distal reinforcement band 202are each annular in shape.

After molding, cuff 35 can be attached to distal band 31 by passing aneedle with suture 208 through cuff 35 and distal band 31. Suture 208can be a continuous, non-bioerodable fiber or thread that is looped in ahelical manner through the outer perimeter of distal band 31. Oppositeends of suture 208 can be tied in a knot 208 a to prevent loosening.Portion 29 a of ring wall 29 extends distally beyond distal band 31.Portion 29 a helps to center the hole in cuff 35 with ring channel 14 sothat no portion of cuff 35 obstructs ring channel 14. In subsequentclinical use of attachment ring 22, cuff 35 is attached to a patient'sheart and ring clamp 24 can be used to secure inflow conduit 10 withinring channel 14.

The molding process allows ring seal 34 to be formed, in a consistentmanner, with a diameter and round shape that corresponds to the size ofinflow conduit 10, so that a fluid-tight seal between attachment ring 22and exterior surfaces of inflow conduit 10 results when inflow conduit10 is disposed within attachment ring 22

In FIGS. 47 a-47 c, another embodiment of attachment ring 22 is formedby molding a polymer into a sheet in which fiber mesh 206 is embedded orencased. Suitable materials for the polymer and fiber mesh can be asdescribed for FIGS. 46 a-46 d. As shown in FIGS. 47 a and 47 b,attachment ring 22 can be made by cutting out a rectangular strip 210from the flat sheet, rolling strip 210 so that opposite ends 212 of thestrip overlap, and bonding ends 212 together to form a fluid-tight seam214.

Next, cuff 35 can be attached around distal portion 216 of the rolledstrip by passing a needle with suture 208 through cuff 35 and distalportion 216. A single, continuous piece or several pieces of suture 208can be used to secure proximal edge 218 and distal edge 220 of cuff 35to distal portion 216 of the rolled strip. In subsequent clinical use ofattachment ring 22, cuff 35 is attached to a patient's heart and ringclamp 24 can be used to secure inflow conduit 10 within ring channel 14.Interior edge 214 a of seam 214 extends through the entire length ofring channel 14. End 212 a of the strip which forms interior edge 214 acan be tapered in cross-section so as to form a smooth interface withopposite end 212 b. Material can also be added at interior edge 214 a toform the smooth interface. The smooth interface allows the inner surfaceof ring channel 14 to form a fluid-tight seal against inflow conduit 10.

In FIGS. 48 a and 48 d, another embodiment of attachment ring 22 isformed by injection molding a polymer in a mold cavity having geometricfeatures that simultaneously form ring wall 29, distal band 31, ringseal 34, and ring valve 230 as a single, unitary structure. Suitablematerials for the polymer can be as described for FIGS. 46 a-46 d. FIGS.48 a and 48 c show views of the distal end and proximal end,respectively. FIGS. 48 a and 48 b show attachment ring 22 without cuffto better show features of distal band 31.

Attachment ring 22 can be rotationally symmetric about longitudinal axis200, so ring wall 29, distal band 31, and ring seal 34 are each annularin shape. In the illustrated embodiment, ring valve 230 is a quadcuspid(i.e., four-leaflet) valve similar in configuration to valve 16described in connection with FIGS. 12 a and 15 c. Other configurationsfor valve 230 can be implemented, for example and without limitation atricuspid valve (similar to FIG. 14 a), a bicuspid valve (similar toFIG. 15 a), a dome valve, a diaphragm valve (similar to FIG. 15 f), andcombinations thereof. Ring seal 34 forms the circular, inner edge of theproximal opening of ring channel 14. When a cylindrical object (forexample, slitting tool 300 and coring knife 140) is inserted into theproximal opening of ring channel 14, ring seal 34 seals against thecylindrical object and ring valve 230 flexes open. When the cylindricalobject is removed, ring valve 230 closes autonomously to reduce, preventor inhibit fluid from flowing distally through ring valve 230 in thedirection of arrow 231. With attachment ring 22 attached to the heart,ring valve 230 can allow slitting and coring of heart tissue while theheart is beating and pumping without the use of valvular structure 12.

After molding, cuff 35 can be attached to distal band 31 by passing aneedle with suture 208 through cuff 35 and distal band 31, such asdescribed for FIGS. 46 c and 46 d. In subsequent clinical use ofattachment ring 22, cuff 35 is attached to a patient's heart and ringclamp 24 can be used to secure inflow conduit 10 within ring channel 14.

Attachment ring 22, in any of the embodiments described above, mayinclude an alignment feature that allows a slitting tool and coringknife 140 to share common alignment. A slitting tool is shown in FIGS.52 a-52 c. In use, the slitting tool can be inserted into attachmentring 22. When inserting the slitting tool into attachment ring 22, thealignment feature ensures that the flat blade of the slitting tool isoriented in a particular way, as will be described in more detail below.Once aligned, the flat blade extends to form a slit in the heart tissue,then the slitting tool is removed from attachment ring 22. The slitfunctions as a passage through which elements of coring knife 140 can beinserted. When inserting coring knife 140 into attachment ring 22, thealignment feature ensures that rotatable coring abutment 145, such asshown in FIGS. 37 a-37 d, is oriented along the same line as the slitpreviously formed by the slitting tool and thereby allows of easy entryof coring abutment 145 into the heart cavity.

Alignment feature can take the form of a structural feature, such as twoindentations 230 (FIG. 4 a) formed into interface lip 25 at the proximalend of attachment ring 22. Indentations 230 can be shaped and sized toreceive protrusions 346 on the exterior surface of the slitting tool(see FIG. 52 a) and protrusions 411 on the exterior surface of thecoring knife (see FIG. 54). Indentations 230 allow for “blind” alignmentwhereby engagement of indentations and protrusions provide tactilefeedback to the surgeon or other user which indicates proper alignment.Alignment feature can also take the form of a visual indicator, such asindelible markings 232 (FIG. 46 c) in a contrasting color and/or anembossed marking applied on interface lip 25. In use, a pair ofprotrusions or markings on the exterior surface of the slitting tool canbe aligned with markings 232 during insertion of the slitting tool intoattachment ring 22. Subsequently, a pair of protrusions or markings onthe exterior surface of coring knife 140 can be aligned with markings232 during insertion of coring knife 140 into attachment ring 22.

Referring again back to FIG. 7 a, clamp 24 can be disposed around thecentral portion of attachment ring wall 29 located between interface lip25 and cuff 35. Clamp 24 can be installed and removed from attachmentring 25 by translating it axially, in a direction along longitudinalaxis 200, onto attachment ring 22 until it reaches the central portionof attachment ring wall 29. However, in cases where clamp 24 has limitedability enlarge its clamp diameter 38, interface lip 25 and cuff 35could interfere with axial translation of attachment ring 22, makinginstallation and removal of attachment ring 22 difficult especiallyafter attachment ring 22 has been secured to heart tissue.

In FIGS. 49 a-49 d, another embodiment of clamp 24 is shown havingmultiple linkages that allow clamp 24 to be easily installed and removedfrom attachment ring 22, either before or after attachment ring 22 hasbeen secured to heart tissue. The linkages are in the form of firstcurved piece 240, second curved piece 242, lever 244, and third curvedpiece 246. When clamp 24 is closed (FIG. 49 a), inner surfaces of first,second and third curved pieces 240, 242, 246 form a circle havingdiameter 247 needed to allow the curved pieces to apply pressure toattachment ring wall 29 in order to secure inflow conduit 10 toattachment ring 22. Diameter 247 can be about the same as or slightlysmaller (for example, 5%, 10%, or 20% smaller) than the outer diameterof attachment ring wall 29. The linkages can be pivoted relative to eachother so as to create an opening that is larger that the outer diameterof attachment ring wall 29. With this ability, attachment ring 22 can beinstalled and removed from attachment ring 22 in a manner that avoidsinterference from interface lip 25 and cuff 35.

Referring to FIG. 49 b, the ends of first curved piece 240 and secondcurved piece 242 are pivotally connected to each other by primary hinge241. The opposite end of first curved piece 240 has hook 245. Theopposite end of second curved piece 242 is connected to lever 244 byfirst lever hinge 248. Second lever hinge 250 connects medial part 252of lever 244 to one end of third curved piece 246. Medial part 252 isdisposed between two legs 254 of third curved piece 246. The oppositeend of curved piece 246 has cylindrical catch 256. Cylindrical catch 256connects legs 254 together and is sized and shaped to fit within hook245.

FIG. 49 a shows clamp 24 when closed. Lever 244 is disposed withingroove 243 (FIG. 49 b) formed within second curved piece 242 and betweenlegs 254 of third curved piece 246. Cylindrical catch 256 is seatedwithin hook 245. First lever hinge 248 is positioned adjacent hook 245.

When clamp 24 is closed, movement of third curve piece 246 along thedirection of arrow 260 is prevented by the presence of attachment ringwall 29 and inflow conduit 10 within clamp 24. That is, attachment ringwall 29 and inflow conduit 10 prevent inner diameter 247 of clamp 24from getting smaller.

To open clamp 24, a person can pull protrusion 258 at the free end oflever 244 radially outward in the direction of arrow 262, as shown inFIG. 49 b. Movement of protrusion 258 along arrow 260 causes cylindricalcatch 256 to move along arrow 260, without requiring inner diameter 247to get smaller. Thus, the presence of attachment ring wall 29 and inflowconduit 10 within clamp 24 does not prevent cylindrical catch 256 fromdisengaging hook 245 when protrusion 258 is pulled along arrow 260. Oncedisengaged first curve piece 240 can be pivoted about primary hinge 241to create an opening that is substantially larger than diameter 247, asshown in FIG. 49 c.

Clamp 24 can have a provision for locking lever 244 in the closedposition. Through hole 264 is formed through the free end of lever 244.When in the closed position, as shown in FIG. 49 a, first opening 266 ofthe through hole is exposed and second opening 268 (FIG. 49 b) isdisposed within groove 243 in second curved piece 242. Second opening268 faces the opening of through hole 267 in second curved piece 242which extends to the outer surface of second curved piece 242. Throughhole 264 and through hole 267 can be aligned so as to be coaxial, whichallows a suture to be looped through both through holes. The sutureprevents lever 244 from moving out in direction of arrow 262 and therebykeeps clamp 24 closed. Opposite ends of the suture can be tied togetherin a knot to keep the suture in place. The suture can be cut to allowits removal and to allow clamp 24 to be opened.

In FIGS. 50 a and 50 b, another embodiment of clamp 24 is shown having asingle, unitary structure in the form of ring 270 with detachable ends.The ends have ratchet features that interlock with each other and allowinner diameter 272 of ring 270 to become smaller. First end 274 includesguard member 276 and ratchet member 278 with a plurality of radiallyinward facing teeth 280. Second end 282 includes ratchet member 284 witha plurality of radially outward facing teeth 286. Ratchet member 284 isdisposed within an open channel between guard member 276 and ratchetmember 278. When clamp 24 is open, as shown in FIGS. 50 a and 50 b, gap280 exists between the free end of ratchet member 284 and the end of theopen channel between guard member 276 and ratchet member 278. Gap 280allows first end 274 and second end 282 to pushed together, which causesteeth 280 and teeth 286 to engage each other. Teeth 280 and teeth 286are configured to slip past each other when first end 274 and second end282 are pushed together and are configured to engage each other toprevent first end 274 and second end 282 from subsequently moving apartfrom each other. In use, clamp 24 can be disposed around attachment ringwall 29 of attachment ring 22. Guard member 276 prevents attachment ringwall 29 from being pinched within gap 280.

Ring 270 functions like a spring in that it stores spring energy whenfirst end 274 and second end 282 are pushed together. Ring 270 can beformed by injecting a polymer into a mold cavity that includes geometricfeatures that simultaneously form guard member 276, ratchet member 278,teeth 280, ratchet member 284, and teeth 286 as a single, unitarystructure. Through hole 288 is formed in first end 274. Through hole 290is formed in second end 282. Through hole 288 and through hole 290 canreceive tips of a tool for pushing first end 274 and second end 282together. Through hole 300 is formed in ratchet member 278. Opposingteeth 280, 286 can be disengaged from each other by inserting a tool inthrough hole 300 and pulling radially outward. When opposing teeth 280,286 disengage, first end 274 and second end 282 autonomously move apartfrom each other due to the spring energy stored in ring 270.

After pushing first end 274 and second end 282 together, a suture can belooped into through hole 300 and through hole 290 as a security measureto prevent the ratchet members from inadvertently disengaging. Oppositeends of the suture can be tied together in a knot to keep the suture inplace. The suture can be cut to allow its removal and to allow ratchetmembers to disengage and inner diameter 272 to enlarge.

When clamp 24 is open, as shown in FIGS. 50 a and 50 b, inner diameter272 is larger than the outer diameter of attachment ring wall 29 ofattachment ring 22. When clamp 24 is closed by pushing the first end 274and second end 282 together, inner diameter 272 corresponds to the sizeof inflow conduit 10 plus the thickness of attachment ring wall 29, sothat a fluid-tight seal between attachment ring 22 and exterior surfacesof inflow conduit 10 results when inflow conduit 10 is disposed withinattachment ring 22.

In FIG. 51, another embodiment of clamp 24 is shown having ratchetmembers 278, 284, each with only one tooth 286, 280. Other embodimentsmay have any number of teeth, as may be needed, to provide additionalengagement and/or to allow clamp 24 to be used with attachment rings 22and inflow conduits 10 of different sizes.

After attachment ring 22 is attached to heart apex 119, foreblade 152 ofcoring knife 140 of FIG. 38 can be used to form a slit through theepicardium and into the myocardium at heart apex 119. Alternatively,slitting tool 300 of FIGS. 52 a-52 c can be used to form the slit intothe heart.

As shown in FIG. 52 a, cylindrical housing 302 has front end 304 andrear end 306. Rear end 306 includes radially protruding handles 308.Spring-loaded actuator 310 protrudes axially out of rear end 306 and isconnected to a flat blade contained within housing 302. Pushing actuator310 axially forward in the direction of arrow 312 causes the flat bladeto extend out of slit opening 314 at front end 304.

As shown in FIG. 52 b, spring 316 is contained within a rear segment ofhousing 302. Rear end 318 of spring 316 is attached to a medial segmentof actuator 310. Forward end 320 of spring 316 abuts wall 322 withinhousing 302. Spring 316 and flat blade 326 are contained within housing302 at opposite sides of wall 322. Spring 316 is under compression andkeeps the flat blade completely retracted within housing 302 until auser pushes actuator 310. Actuator 310 extends through a hole in wall322. Forward end 324 of actuator 310 is connected to flat blade 326. Asactuator 310 is translated forward in the direction of arrow 312,actuator 310 compresses spring 316 against wall 322 and forward end 324pushes blade 326 out of front end 304 of housing 302.

FIG. 52 c shows flat blade 326 extending out of slit opening 314 afteractuator 310 has been pushed forward. Blade seal 328 is contained withinhousing 302 and is located adjacent slit opening 314 at front end 304.Flat blade 326 passes through blade seal 328 which includes a pair offlexible wipers 330 that face each other. Wipers 330 extend across theentire blade width 332 (FIG. 52 b) and press against opposite sides offlat blade 326, thereby preventing blood from flowing into the rearsegment of housing 302. Blade seal 328 can be made of silicone rubber orother resilient polymer. In other embodiments, blade seal 328 is a stripof polymer foam with a slit equivalent in size to blade width 332.

In use, front end 304 of housing 302 is inserted into attachment ring 22or the combination of valvular structure 12 and attachment ring 22.Outer diameter 330 of housing 302 and ring seal 34 of attachment ring 22can be sized such that a substantially fluid-tight seal is formedbetween the exterior surface of housing 302 and ring seal 304 when frontend 304 is inserted into through attachment ring 22. When flat blade 326punctures a beating heart and is retracted, blood from the heart mayflow into attachment ring 22 and into slit opening 314 of housing 302.Blade seal 328 minimizes blood loss by preventing or inhibiting bloodfrom flowing through and out of slitting tool 300.

In some embodiments, outer diameter 330 of housing 302 and housing seal47 (FIG. 10 a) of valvular structure 12 can be sized such that asubstantially fluid-tight seal is formed between the exterior surface ofhousing 302 and housing seal 47 when front end 304 is inserted intovalvular structure 12 which has been attached to attachment ring 22.When flat blade 326 punctures a beating heart and is retracted, bloodfrom the heart may flow into attachment ring 22, valvular structure 12,and slit opening 314 of housing 302. Blade seal 328 minimizes blood lossby preventing or inhibiting blood from flowing through and out ofslitting tool 300.

Referring again to FIG. 52 a, stop feature 340 is located on housing 320at a predetermined distance 342 from the forward most tip 344 ofslitting tool 300. Stop feature 340 prevents tip 344 from pushing intothe heart when slitting tool 340 is being positioned within attachmentring. Stop feature 340 includes a pair of protrusions 346 sized andshaped to fit within alignment features on attachment ring 22 and/orvalvular structure 12.

In some embodiments, predetermined distance 342 is equivalent to or afew millimeters less than the longitudinal height of attachment ring 22.The longitudinal height can be the maximum dimension as measured alongthe longitudinal axis of attachment ring 22. The longitudinal height ofan exemplary attachment ring is indicated by arrow 348 in FIG. 46 d. Inuse, slitting tool 300 can be inserted by a surgeon or other user intoattachment ring 22 secured to the heart, with no valvular structure 12attached to attachment ring 22. When stop feature 304 abuts interfacelip 25 of attachment ring 22, the user will know that tip 344 ofslitting tool 300 is located at the proper position just above theheart. The user can twist slitting tool 300 about its central axis 301until protrusions 346 become seated within indentations 230 (FIG. 4 a)formed into interface lip 25. When protrusions 346 engage indentations230, the user will know from tactile feed back that slitting tool 300 isin proper rotational alignment. Thereafter, the user can extend flatblade 326 to make a slit through the heart, and then use coring knife140 under the same rotational alignment as slitting tool 300 to form acircular hole around the slit.

In some embodiments, predetermined distance 342 is equivalent to or afew millimeters less than the longitudinal stack height of valvularstructure 12 and attachment ring 22. The longitudinal stack height of anexemplary assembly of valvular structure 12 and attachment ring 22 isindicated by arrow 350 in FIG. 2 b. In use, slitting tool 300 can beinserted by a surgeon or other user into valvular structure 12 andattachment ring 22 which has been attached to the heart. When stopfeature 304 abuts the proximal end of valvular structure 12, the userwill know that tip 344 of slitting tool 300 is located at the properposition just above the heart. The user can twist slitting tool 300about its central axis 301 until protrusions 346 become seated withinalignment features (for example, coupling grooves 71 (FIG. 11 a),alignment groove 497 (FIG. 56 a) and alignment groove (FIG. 57 a))formed into the proximal end of valvular structure 12. When protrusions346 engage the alignment features, the user will know from tactile feedback that slitting tool 300 is in proper rotational alignment.Thereafter, the user can extend flat blade 326 to make a slit throughthe heart, and then use coring knife 140 under the same rotationalalignment as slitting tool 300 to form a circular hole around the slit.

Stop feature 340 can be an annular flange, as illustrated, which can bean integral part of or permanently affixed to housing 320. Protrusions346 can be spaced 180 degrees apart from each other on the circumferenceof stop feature 340. Alternatively, stop feature 304 can be movablealong housing 302 to allow predetermined distance 342 to be adjusted ifdesired.

In FIGS. 53 a-53 f, another embodiment of coring knife 140 is shownhaving pistol-type grip 360, release trigger 362, and abutment controllever 364. FIG. 53 a shows coring knife 140 in its startingconfiguration, in which the plane of coring abutment 145 is in line withlongitudinal axis 366 of coring knife 140, and coring blade 137 iscompletely contained within coring knife case 141. The plane of thecoring abutment 145 is defined by a plurality of points on the outerperimeter of coring abutment 145. Coring abutment 145 is held inposition by two support rods 368. Control arm 146 is disposed betweensupport rods 368. Support rods 368 and control arm 146 extend into theforward end of slide assembly 370 and into central shaft 372 (FIG. 53 d)which is fixedly attached to grip 360. The forward ends of support rods368 and control arm 146 are pivotally connected to different points oncoring abutment 145. Control arm 146 is operatively coupled to abutmentcontrol lever 364.

As shown in FIG. 53 b, the forward ends of support rods 368 are attachedto coring abutment 145 at points 372 that form pivot line 374 that issubstantially perpendicular to longitudinal axis 366. The forward endsof support rods 368 can be attached to coring abutment 145 by a slenderpin that extends within coring abutment 145. Control arm 146 is attachedto coring abutment 145 at point 376 which is longitudinally offset byoffset distance 377 from points 372 so as to be closer to forward mosttip 378 of coring abutment 145. The forward end of control arm 146 canbe attached to coring abutment 145 by another slender pin that extendswithin coring abutment 145. Due to offset distance 377, movement ofcontrol arm 146 rearward in the direction of arrow 380, while supportrods 368 remain stationary, causes coring abutment 145 to rotate aboutpivot line 374. As shown in FIG. 53 c, when point 376 has moved rearwardby a distance equivalent to offset distance 377, the plane of coringabutment 145 is substantially perpendicular to longitudinal axis 366.Control arm 146 is operatively coupled to control lever 364 which ispivotally attached to grip 360. As shown in FIG. 53 d, pivoting controllever 364 upward in a direction along arrow 382 causes control arm 146to move rearward along arrow 380 until the plane of abutment surface 145is substantially perpendicular to longitudinal axis 366. Control lever364 includes safety latch 384. When control lever 364 is in a loweredposition (FIG. 53 a), safety latch 384 is in front of knob 385 of slideassembly 370 where it prevents slide assembly 370 from inadvertentlysliding toward coring abutment 145. When control lever 364 is in araised position (FIG. 53 d), safety latch 384 has moved away from knob385 and slide assembly 370 can slide toward coring abutment 145 whenrelease trigger 362 is pressed by the user.

Slide assembly 370 comprises coring blade 137, coring knife case 141,and internal sleeve 386. Internal sleeve 386 (FIG. 53 f) is disposedaround and slides longitudinally over central shaft 372. Coring knifecase 141 is fixedly attached to internal sleeve 386. Internal sleeve 386includes a pair of linear slots 388 (FIG. 530 which extend substantiallyparallel to longitudinal axis 366. Pin 390 (FIG. 53 e) protrudes fromcentral shaft 372 into linear slots 388 and thereby prevents internalsleeve 386 from rotating relative to central shaft 372 and grip 360. Pin390 prevents internal sleeve 386 from rotating relative to central shaft372. Internal sleeve 386 also includes a series of holes 392 arrangedalong one or more lines substantially parallel to longitudinal axis 366.A ball detent mechanism within central shaft 372 engages one or more ofthe holes 392 to prevent slide assembly 370 from sliding freely oncentral shaft 372. Ball detent mechanism is operatively coupled torelease trigger 362. Release trigger 362 is spring loaded in such a waythat ball detent mechanism prevents slide assembly 370 from sliding whenno force is applied to release trigger 362.

When a force is applied by a user to depress release trigger 362, balldetent mechanism disengages holes 392. The user may then grasp slideassembly 370 and slide it forward toward coring abutment 145, as shownin FIG. 53 e. In use, slide assembly 370 is preferably moved forward toa point where forward edge 396 of coring knife case 141 touches or isjust above the heart tissue 398. It is understood that coring knife case141 is now located within the ring channel 14 of attachment ring 22 orvalvular structure 12 combined with attachment ring 22. It is alsounderstood that the coring abutment 145 is located within the heartcavity and abuts the heart tissue from the side opposite coring knifecase 141. When forward edge 396 of coring knife case 141 is at thedesired position, the user may let go of release trigger 362 so thatball detent mechanism engages holes 392 and locks in the longitudinalposition of coring knife case 141.

At this stage, coring blade 137 remains completely retracted withincoring knife case 141. Coring blade 137 is a hollow cylinder the forwardend of which forms sharp circular tip 400. The rear end of coring blade137 is fixedly attached to the front end of rotatable control sleeve402. Helical coring guide or slot 147 is formed into the rear segment ofrotatable control sleeve 402. Knob 385 is fixedly attached to the rearend of control sleeve 402. Manual rotation of knob 385 by the usercauses control sleeve 402 and coring blade 137 to rotate relative tocoring knife case 141 and internal sleeve 386 which are held stationaryby ball detent mechanism and pin 390. Guide peg 148 protrudes fromcoring knife case 141 into helical slot 147 of control sleeve 402. Thus,rotation of knob 385 simultaneously causes control sleeve 402 and coringblade 137 to translate longitudinally toward coring abutment 145.Rotation in the reverse direction causes control sleeve 402 and coringblade 137 to translate longitudinally away from coring abutment 145. Itis understood that knob 385 allows the user to have complete control ofthe force applied by coring blade and complete control of coring bladeadvancement by each turn of knob 385. In this embodiment, there is nospring loading on coring blade 137 that might otherwise remove completecontrol of applied force from the user.

In FIG. 53 f, knob 385 has been rotated until circular tip 400 of coringblade 137 has pressed against coring abutment 145. In use, coring blade137 would have made a circular cut entirely through the myocardium. Around piece of polymer foam, absorbent material, or resilient material,can be disposed within the rear end of the coring blade 137 to sealaccess holes for support rods 368 and control arm 146, and thereby stopor soak up blood and prevent blood from rushing into the rear portionsof coring knife 140. A cylindrical portion of the myocardium would becompletely detached from the remainder of the heart and contained withincoring blade 137. The user may then pull coring knife 140 rearward, in adirection substantially parallel to longitudinal axis 366, therebyextracting the cylindrical portion of the myocardium out from beneathattachment ring 22 or the combination of valvular structure 12 andattachment ring 22. If the procedure is performed while the heart isbeating, either ring valve 230 (FIG. 48 b) of attachment ring 22 orvalve 16 (FIG. 2 a) of valvular structure 12 autonomously close aftercoring knife 140 is pulled out and thereby prevents significant loss ofblood.

Use of coring knife 140 can begin by inserting coring abutment 145oriented as shown in FIG. 53 a into the slit previously formed byslitting tool 300. To facilitate insertion into the slit, the plane ofthe coring abutment 145 should be aligned in the same direction as theslit. Establishing the proper alignment can be difficult because thevisual line of sight to the slit could be obstructed by the coring knifeitself, by ring valve 230 (FIG. 48 b) of attachment ring 22, or by valve16 (FIG. 2 a) of valvular structure 12. An alignment feature on theproximal end of attachment ring 22 or valvular structure 12 can be usedby the user to align coring abutment 145 to the slit in the heart. Thealignment feature can be in the form of indentations 230 (FIG. 4 a)formed into interface lip 25 at the proximal end of attachment ring 22and/or indelible markings 232 (FIG. 46 c) in a contrasting color appliedon interface lip 25. The alignment feature can be in the form ofcoupling grooves 71 (FIG. 11 a) or alignment groove 497 (FIGS. 56 a and57 a) formed into the proximal end of valvular structure 12 or be in theform of indelible markings applied to the proximal end of valvularstructure 12. A corresponding feature on coring knife case 141, such asa protrusion and/or indelible markings, can be visually aligned orphysically engaged with the alignment feature on attachment ring 22 orvalvular structure 12.

As previously discussed, while the user depresses release trigger 362,slide assembly 370 can be moved forward to a point where forward edge396 of coring knife case 141 touches or is just above the heart tissue398. Positioning forward edge 396 to the desired position relative tothe surface of the heart may be difficult to perform visually if theline of sight to the heart surface is obstructed by coring knife 140,valvular structure 12, and/or attachment ring 22.

As shown in FIG. 54, stop feature 410 can be located on coring knifecasing 141 at a predetermined distance 412 from forward edge 396 ofcoring knife case 141. Stop feature 410 prevents forward edge 396 frompushing into the heart when slide assembly 370 is being positionedwithin attachment ring 22. Stop feature 410 can include protrusions 411sized and shape to fit within the alignment feature on attachment ring22 or valvular structure 12, and/or can include indelible markings foraligning coring abutment 145 with the slit in the heart.

In some embodiments, predetermined distance 412 is equivalent to or afew millimeters less than the longitudinal height of attachment ring 22.The longitudinal height of an exemplary attachment ring is indicated byarrow 348 in FIG. 46 d. In use, coring knife 140 can be inserted by asurgeon or other user into attachment ring 22 secured to the heart, withno valvular structure 12 attached to attachment ring 22. When stopfeature 410 abuts interface lip 25 of attachment ring 22, the user willknow that forward edge 396 of coring knife case 141 is located at theproper position. Thereafter, the user can let go of release trigger 362to lock coring knife case 141 in place, then rotate knob 385 to extendcoring blade 137 out of coring knife case 141 and into the heart.

In some embodiments, predetermined distance 412 is equivalent to or afew millimeters less than the longitudinal stack height of valvularstructure 12 and attachment ring 22. The longitudinal stack height of anexemplary assembly of valvular structure 12 and attachment ring 22 isindicated by arrow 350 in FIG. 2 b. In use, coring knife 140 can beinserted by a user into valvular structure 12 and attachment ring 22which has been attached to the heart. When stop feature 410 abuts theproximal end of valvular structure 12, the user will know that forwardedge 396 of coring knife case 141 is located at the proper position.Thereafter, the user can let go of release trigger 362 to lock coringknife case 141 in place, then rotate knob 385 to extend coring blade 137out of coring knife case 141 and into the heart.

Stop feature 410 can be an annular flange which can be an integral partof or permanently affixed to coring knife casing 141. Alternatively,stop feature 410 can be movable along coring knife casing 141 to allowpredetermined distance 412 to be adjusted if desired.

Referring again to FIG. 54, coring abutment 145 has abutment surface 414that is substantially flat or planar. Abutment surface 414 faces coringknife case 141 after control lever 364 has been pivoted upward. In use,abutment surface 414 supports the interior surface of the heart ascoring blade 137 rotates, extends out of coring knife case 141, and cutsfrom the exterior surface of the heart. Coring blade 137 ultimatelypresses against abutment surface 414 when cutting is complete.

In other embodiments, such as shown in FIG. 55, abutment surface 414 hasa raised central portion 416 and tapered edges 418 at the outercircumference of coring abutment 145. As coring blade 137 rotates andmoves closer to abutment surface 414, raised central portion 416 entersinto coring blade 137 and tapered edges 418 abut forward edge 396 ofcoring blade. Raised central portion 416 and tapered edges 418 align thecenter of abutment surface 414 with the center of forward edge 396 ofcoring blade 137. Raised central portion 416 and tapered edges 418prevent misalignment in which a portion of forward edge 396 extendsbeyond the outer circumference of coring abutment 145 and fails to pressagainst abutment surface 414. Abutment surface 414 can be convex,spherical, conical or other shape having raised central portion andtapered edges.

In FIGS. 56 a-56 d, another embodiment of valvular structure 12 is shownhaving a spring-loaded hinge. Valvular structure 12 is shown withattachment ring 22 in FIGS. 56 a and 56 b. Valvular structure 12 isshown without attachment ring 22 in FIGS. 56 c and 56 d. Valvularstructure is divided into two halves which are hinged together at oneend and have locking features at the other end. The hinge facilitatesinstallation onto and removal from attachment ring 22, as shown in FIG.56 b. Each half of valvular structure 12 includes half of housing 18 andhalf of valve 16. Housing 18 encases valve 16 which has a quadcupsidconfiguration. Valve 16 can be as described in connection with FIGS. 10a-10 e, 12 a-15 f or any of the previously described embodiments. Inuse, housing 18 encases interface lip 25 of attachment ring 22.Attachment ring 22 can be as described in connection with FIG. 4 a, 4 b,7 a, 7 b or 46 a-46 c.

As shown in FIG. 56 b, housing first portion 46 and housing secondportion 54 form two longitudinal halves of housing 18. The longitudinalhalves are formed by a “cut” that runs along longitudinal axis 187.Housing first portion 46 and housing second portion 54 are separated byan imaginary plane coincident with longitudinal axis 187. Housing firstportion 46 and housing second portion 54 each have, at one end thereof,first and second hinge members 450 a,b that mate with each other and arepivotally connected to each other by hinge pin 452. Housing firstportion 46 and housing second portion 54 each have, at the opposite endthereof, first and second lock members 454 a,b which are locked togetherby slide member 456. Slide member 456 is slidably coupled first lockmember 454 a. Slide member 456 has groove 460 sized and shaped toreceive rib 462 on second lock member 454 b. When housing 18 is closed,as shown in FIG. 56 a, slide member 456 is at a distal position in whichrib 462 is retained within slide member 456, thereby keeping housingfirst portion 46 and housing second portion 54 closed and sealedtogether. To open housing 18, a user moves slide member proximally inthe direction of arrow 464 (FIG. 56 a), which disengages slide member456 from rib 462 and allows housing first portion 46 and housing secondportion 54 to pivot on hinge pin 452 and open as shown in FIG. 56 b.Slide member 456 includes longitudinal rib 457 which a user can graspwith his/her fingers or a tool in order to move slide member 456.

Housing channel 58 runs through the center of housing 18, through valve16 and communicates with ring channel 14 of attachment ring 22. Housingfirst portion 46 includes de-airing port 62 which includes athrough-hole that extends from the exterior of housing 18 to the portionof housing channel 58 between valve 16 and attachment ring 22.

The interior of housing first portion 46 and housing second portion 54can be mirror images of each other, with the exception of the de-airingport through hole. Thus features shown add/or described for housingfirst portion 46 is present in housing second portion 54, and viceversa. The interior of housing first portion 46 and housing secondportion 54, in combination, can be rotationally symmetric aboutlongitudinal axis 187. Thus, features within housing channel 58 extendfor about 180 degrees on housing first portion 46 and about 180 degreeson housing second portion 54.

When housing 18 is closed, interface lip 25 of attachment ring 22 isretained within interface groove 466. Interface groove 466 is formedbetween distal flange 468 and guide flange 470. Proximal facing surface472 of guide flange 470 can be sloped so as to guide slitting tool 300or coring knife 140 into attachment ring 22. A pair of proximal flanges474 form valve groove 61 which retains valve shoulder 59 of valve 16.

When housing 18 is closed, first gasket 476 and second gasket 478 arecompressed and form a fluid-tight seal between housing first portion 46and housing second portion 54. First gasket 476 is located adjacentfirst and second hinge members 450 a,b. Second gasket 478 is locatedadjacent first and second lock members 454 a,b. First gasket 476 andsecond gasket 478 can be made of a flat piece of silicone rubber foam orother resilient polymer material having edges which match the interioredges of housing 18, including edges of distal flange 468, guide flange470, and proximal flanges 474. A first pair of handles 480, each in theform of a longitudinal rib, are located adjacent to lock members 454 a,454 b and protrude from housing first portion 46 and housing secondportion 54. A user can pinch handles 480 together, using his/her fingersor a tool, when closing housing 18 in order to compress first gasket 476and second gasket 478 sufficiently to allow slide member 456 to be slidonto rib 462.

FIGS. 56 c and 56 d are views of the proximal end of housing 18. Asecond pair of handles 482 are located adjacent to hinge members 450 a,450 b and hinge pin 452. As shown in FIG. 56 a, each handle 482 has abase 484 adjacent the distal end of housing 18 and longitudinal wingmember 486 that extends proximally from base 484. Base 484 and wingmember 486 are attached to housing 18. Through hole 488 is formed intobase 484. Groove 490 extends from through hole 488 and onto wing member486. Torsion spring 492 (FIG. 56 c) is disposed between handles 482.Straight ends 496 of torsion spring 492 are retained within groovesformed in wing members 486. Torsion spring 492 is under compression suchthat straight ends 496 constantly push wing members 486 apart, therebybiasing housing 18 closed. Hinge pin 452 extends through helical segment494 of torsion spring 492, thereby preventing torsion spring 492 fromdetaching from wing members 486. After moving slide member 456 to aproximal position in which rib 462 is released, a user may squeezehandles 462 together to overcome torsion spring 492 and thereby openhousing 18 as shown in FIG. 56 d. The user may engage a tool on grooves490 and/or through holes 488 in order to squeeze handles 462 together.

Alignment groove 497 is formed into proximal edge 498 of each of housingfirst portion 46 and housing second portion 54. Alignment groove 497 canbe sized and shape to receive protrusions 346 on the exterior surface ofthe slitting tool 300 (FIG. 52 a) and protrusions 411 on the exteriorsurface of coring knife 140 (FIG. 54). Engaging slitting tool 300 andcoring knife 140 into grooves 497 can ensure that coring abutment 145 ofcoring knife 140 is aligned with the slit previously formed by flatblade 326 of slitting tool 300. Alignment marking 498 is embossed on theside of each of housing first portion 46 and housing second portion 54to facilitate alignment of slitting tool 300 and coring knife 140.

In FIGS. 57 a-57 d, there is shown an embodiment of valvular structure12 which can be installed with C-clamp tool 600 (FIG. 58 a). Valvularstructure is divided into two identical halves which can be lockedtogether and separated, as desired, to facilitate installation onto andremoval from attachment ring 22 (not shown in FIGS. 57 a-57 b). Housing18 encases valve 16 which has a quadcupsid configuration. Valve 16 canbe as described in connection with FIGS. 10 a-10 e, 12 a-15 f or any ofthe previously described embodiments. In use, the proximal end ofattachment ring 22 can abut the distal end of housing 18, instead ofbeing encased within housing 18. Housing 18 is rotationally symmetricabout longitudinal axis 187 such that for each feature on housing 18there is an identical feature located 180 degrees away.

Housing first portion 46 and housing second portion 54 are identical toeach other so for any feature shown and/or described for one of them,there is a corresponding feature present on the other. As shown in FIG.57 b, opposite ends of housing first portion 46 have hinge members 510which interlock with that of housing second portion 54. Each hingemember 510 has a through hole 511. Interlocking hinge members 510 areheld together by slidable hinge pin 520 having a first straight leg 522and a second straight leg 524. First straight leg is slideable withinthrough holes 511 of hinge members 510. Second straight leg 524 isslideable within through hole 526 formed in wing 528 at the proximal endof housing 18.

When housing 18 is closed, as shown in FIG. 57 a, each hinge pin 520 isin a distal position, and first straight leg 524 holds hinge members 510together. To open housing 18, a surgeon or other user may move hinge pin520 proximally from the distal position, in the direction of arrow 530,which causes first straight leg 522 to move and allow hinge members 510to pull apart from each other, as shown in FIG. 57 b. Foot member 532 onsecond straight leg 524 abuts wing 528, which prevents hinge pin 520completely pulling out and detaching from housing 18. When one of thehinge pins 520 is moved proximally and the other hinge pin 520 is in thedistal position, housing first portion 46 and housing second portion 54can pivot apart from each other so that housing 18 opens. When bothhinge pins 520 are moved proximally, housing first portion 46 andhousing second portion 54 can completely detached from each other. Whenhousing first portion 46 and housing second portion 54 are detached orpivoted apart from each other, valve 16 can be pulled out from betweenproximal flanges 534 within housing channel 58 and be completelyremoved.

Housing first portion 46 and housing second portion 54 each havede-airing port 62 which includes a through-hole the extends from theexterior of housing 18 to the portion of housing channel 58 betweenvalve 16 and the distal end of housing 18. Housing first portion 46 andhousing second portion 54 each have gasket 536, alignment pins 538, andalignment holes 540. Alignment pins 538, and alignment holes 540 arelocated on opposite ends of housing first portion 46 and housing secondportion 54, so that alignment pins 538 of one of housing portion isreceived into alignment holes 540 of the other housing portion. Whenhousing 18 is closed, gasket 536 is compressed and forms a fluid-tightseal between housing first portion 46 and housing second portion 54.Gasket 536 can be bonded to the housing portion and can be made of aflat piece of silicone rubber foam or other resilient polymer materialhaving edges which match the interior edges of housing 18, including thecontours of proximal flanges 534 and base flange 552.

Alignment groove 542 is formed into proximal edge 544 of each of housingfirst portion 46 and housing second portion 54. Alignment groove 542 canbe sized and shape to receive protrusions 346 on the exterior surface ofthe slitting tool 300 (FIG. 52 a) and protrusions 411 on the exteriorsurface of coring knife 140 (FIG. 54). Engaging slitting tool 300 andcoring knife 140 into grooves 496 can ensure that coring abutment 145 ofcoring knife 140 is aligned with the slit previously formed by flatblade 326 slitting tool 300.

Referring to FIG. 57 b, alignment groove 542 can be configured in such away that a cylindrical protrusion can be pushed distally into proximalopening 544 and snapped into and retained within channel 546. Retentionis provided by proximal opening 544 which has width 548 that is slightlysmaller than width 550 of channel 546. In some embodiments, valvularstructure 12 can be carried at the end of an installation tool havingcylindrical protrusions engaged with alignment grooves 542. Theinstallation tool can be used to position valvular structure 12 at adesired position adjacent attachment ring 22 during a surgicalprocedure. For example and without limitation, the installation tool canbe slitting tool 300.

FIGS. 57 c and 57 d show views of the distal end of housing 18 whenclosed. Housing first portion 46 and housing second portion 54 each havebase flange 552. Base flange 552 is rigid and can be made of the samematerial used to form the remainder of housing 18. Base gasket 554 isadhered to base flange 552. Base gasket 554 can be made of a flat pieceof silicone rubber foam or other resilient polymer material having edgeswhich substantially match the edges of base flange 552.

Base flange 552 is sized and shaped to fit within rotatable withinC-clamp 600 (FIG. 58 c), which will be described below. Inner surface556 of each base flange 552 has the shape of a half circle sized toallow slitting tool 300, coring knife 140, and inflow conduit 10 to passthrough. The Outer surface of base flange 552 includes an outer curvedsurface 558 between two outer straight surfaces 560. Outer straightsurfaces 560 are substantially parallel to each other and are offsetfrom each other by distance 562 (FIG. 57 d). The curvature of outercurved surface 558 is defined by diameter 564. When the housing 12 isclosed, diameter 564 corresponds to the distance, as measured throughthe geometric center 566 of housing, between outer curved surface 558 onhousing first portion 46 and outer curved surface 558 on housing secondportion 54. Diameter 564 is greater than distance 562.

Outer curved surface 558 and outer straight surface 560 define the edgeof compression surface 561 of base flange 552. Compression surface 561(FIGS. 57 a and 57 b) faces in the proximal direction and, as explainedbelow, can be pushed by C-clamp 600 to compress base gasket 554 ontoattachment ring 22. Side groove 568 is formed into a portion of theouter surface of base flange 552 and is disposed distal to compressionsurface 561. Stop wall 570 at one end of side groove 568 is formed intocurved surface 558. Side groove 568 extends from stop wall 570 along thecircumference of curved surface 558 until side groove 568 opens onto andintersects one of the outer straight surfaces 560 at groove entrancepoint 572.

FIGS. 58 a-58e, 59 a and 59 b show C-clamp 600 used for stabilizingattachment ring 22 after attachment ring 22 has been secured the heart,and for aligning and clamping valvular structure 12 onto attachment ring22. C-clamp 600 facilitates alignment and control during use of slittingtool 300 and coring knife 140 and during insertion of inflow conduit 10into attachment ring 22.

C-clamp 600 can be attached to a handle 602 for inserting C-clamp 600into the body of a patient. Handle 602 can be of sufficient length toreach the apex of the heart with a portion of the handle extending outof the patient's chest no more than about 5 to 6 inches from the chestsurface. In some embodiments, handle 602 is rigid and has a fixedcurvature. In some embodiments, the curvature of the handle 602 can beadjusted and locked by the user. In some embodiments, as shown in FIG.58 b, handle 602 can be articulated and have a plurality of segments 604connected to each other by joints 606 which can be selectively loosenedand locked by knob 608 to allow the curvature of handle 602 to beadjusted. Knob 608 can be configured to tighten joints 606 and/or adjusttension in one or more cables that run through the center of segments604, wherein movement of joints depend on the amount of tension in thecables. After the curvature of handle 602 is locked and C-clamp 600 isin the desired position within the patient, handle 602 can be secured toa chest retractor attached to the patient.

Referring to FIGS. 58 c and 58 d, shoulder segment 610 of C-clamp 600 isattached to handle 602. Two arm segments 612 extend from shouldersegment. Free end 614 of arm segments 612 are spaced apart from eachother and define side opening 616 of C-clamp 600. Two finger members 618form the tips of free end 614 of each arm segment 612. Side slot 620 isformed between finger members 618. Distal offset distance 622 separatesthe tips of finger members 618 of one arm segment from the tips offinger members 618 of the other arm segment. Distal offset distance 622corresponds to the width of distal opening 624 at the base of C-clamp600. Edges of distal opening 624 form a U-shape, as shown in FIG. 58 d,which includes distal linear edges 625 that are parallel to each otherand are offset from each other by distal offset distance 622. Distalgroove diameter 648 a (FIG. 58 e) is greater than distal offset distance622. Side opening width 623 separates the base surface of side slot 620of one arm segment from the base surface of side slot 620 of the otherarm segment. In use, interface lip 25 of the attachment ring 22 passesthrough side opening width 623, and distal opening 624 receivesattaching ring wall 29.

The shoulder segment 610 and the arm segments 612 form clamp body 601.Distal groove 632 and proximal groove 644 in clamp body 601 formcylindrical surfaces 628 a, 628 b and ledge surfaces 626 a, 626 b thatintersect each other. In illustrated embodiment, ledge surfaces 626 a,626 b are planar. Cylindrical surfaces run substantially parallel toclamp longitudinal axis 630 and interface with circumferential surfacesof attachment ring 22 and valvular structure 12 when in use. Distalcylindrical surface 626 a of distal groove 632 has a curvature which canbe concentric with the curvature of proximal cylindrical surface 626 bof proximal groove 644. Ledge surfaces 626 a, 626 b are substantiallyplanar and perpendicular to clamp longitudinal axis 630 and interfacewith distal or proximal facing surfaces of attachment ring 22 andvalvular structure 12 when in use. In other embodiments, ledge surfaces626 a, 626 b may include curves or indentations.

FIGS. 59 a and 59 b show C-clamp 600 with various devices. In use,C-clamp 600 is advanced toward attachment ring 22 which has already beensecured to the heart. C-clamp 600 is advanced so that attachment ring 22passes through side opening 616. Interface lip 25 of attachment ring 22passes between fingers 618 and into side slot 620, and ring wall 29 ofattachment ring 22 passes through distal opening 624 of C-clamp. Sideopening width 623 between side grooves 620 is about the same as orslightly larger than the outer diameter of interface lip 25 ofattachment ring 22. Distance 622 between the tips of fingers 618 isabout the same as or slightly larger than the outer diameter of ringwall 29 of attachment ring 22. C-clamp 600 is positioned so thatinterface lip 25 is seated within distal groove 632 of C-clamp 600.Distal ledge surface 626 a of distal groove 632 supports interface lip25.

Proximal opening 634 (FIG. 59 a) of C-clamp 600 is shaped and sized toreceive base flange 552 and base gasket 554 of valvular structure 12 ofFIGS. 57 a-57 d. Exterior surface 626 c of arm segments 612 of C-clamp600 include linear edges 636 and curved edge 638 which correspond inshape to outer curved surface 558 and outer straight surfaces 560 ofbase flange 552. Linear edges 636 are parallel to each other. Curvededge 638 intersects proximal cylindrical surface 628 b. To allow baseflange 552 to pass through proximal opening 634, linear edges 636 andcurved edge 638 have dimensions which about the same as or slightlylarger than outer curved surface 558 and outer straight surfaces 560 ofbase flange 552. Proximal offset distance 642 separates linear edges 636and is about the same as or slightly larger than distance 562 (FIG. 57d) between straight surfaces 560 of base flange 552. Proximal offsetdistance 642 is less than proximal groove diameter 648 a.

As shown in FIG. 58 d, the curvature of the distal cylindrical surface628 a extends between 180 degrees and 300 degrees. In the illustratedembodiment, distal cylindrical surface 628 a extends about 270 degrees.The curvature of the proximal cylindrical surface 628 b extends between180 degrees and 300 degrees. In the illustrated embodiment, proximalcylindrical surface 628 b extends about 270 degrees.

In use, valvular structure 12 is moved distally toward C-clamp 600 inthe direction of arrow 640 (FIG. 59 a), which base flange 552 facingC-clamp 600. Valvular structure 12 is rotated about its longitudinalaxis until outer straight surfaces 560 of base flange 552 aresubstantially parallel with linear edges 636 of C-clamp 600, therebyallowing base flange 552 and base gasket 554 to pass through proximalopening 634. Base gasket 554 contacts interface lip 25 of attachmentring 22. Base flange 552 is seated within proximal groove 644 defined byproximal ledge surface 626 b, proximal cylindrical surface 628 b, andproximal compression surface 650 which intersect each other. Proximalcylindrical surface 628 b extends from side slot 620 on one arm segmentto side slot 620 on the other arm segment, and forms a circular shapehaving proximal groove diameter 648 b (FIG. 58 d) that is about the sameas or slightly larger than diameter 564 (FIG. 57 d) of outer curvedsurface 558 of base flange 552. As shown in FIG. 58 d, proximal groovediameter 648 b is greater than proximal offset distance 642 whichseparates linear edges 636. A portion of proximal cylindrical surface628 b is located below (distal to) linear edges 636 and intersectsproximal compression surface 650, as shown in FIG. 58 e (side view ofC-clamp). A pair of stop pins 652 (FIGS. 58 d and 59 a) protruderadially inward from the portion of proximal cylindrical surface 628 bbelow linear edges 636.

Referring to FIGS. 58 e, distal cylindrical surface 628 a of distalgroove 632 has a curvature having a distal groove diameter 648 a whichis about the same as or slightly greater than the outer diameter ofattaching ring wall 29 of attachment ring 22. The proximal groovediameter 628 b is greater than the distal groove diameter 628 a.Proximal compression surface 650 faces proximal ledge surface 626 b.Distal opening 624 extends through distal ledge surface 626 a. Proximalopening 634 extends through compression surface 650.

After valvular structure 12 is seated within distal groove 644, valvularstructure 12 can be rotated relative to C-clamp 600 about clamplongitudinal axis 630 in the direction of arrow 654 (FIG. 59 b). Toallow for rotation, valvular structure 12 can be pushed distally in thedirection of arrow 640 to compress base gasket 554 of valvular structure12 against interface lip 25 and cause compression surface 561 of baseflange 552 to be longitudinally aligned with or move slightly belowproximal compression surface 650 of C-clamp 600. Thereafter, valvularstructure 12 can be rotated in the direction of arrow 654. Each Stop pin652 of C-clamp 600 prevents rotation in the opposite direction. Duringrotation, stop pin 652 is received within side groove 568 in base flange552. Stop pin 652 enters groove entrance point 572. As valvularstructure 12 is rotated, stop wall 570 at the end of side groove 568moves toward stop pin 652 until they abut each other, which prevents anyfurther rotation. Rotation stops when valvular structure 12 has rotatedone quarter turn (or 90 degrees). After rotation has stopped, as shownin FIG. 59 b, outer curved surface 558 of base flange 552 is locatedbelow (distal to) linear edges 636 of C-clamp 600. Compression surface561 of base flange 552 engages proximal compression surface 650 ofC-clamp 600, which keeps base gasket 554 of valvular structure 12compressed and sealed against interface lip 25 of attachment ring 22.

As shown in FIG. 59 b, alignment assembly 660 is disposed withinproximal edge 544 of valvular structure 12. Protrusions 662 (one visiblein FIG. 59 a) of alignment assembly 660 extend radially outward and areengaged within alignment groove 542 is formed into proximal edge 544.Alignment assembly 660 can be part of a tool having a tip that extendsinto valvular structure 12 and attaching ring 22. Alignment assembly 660can be attached to coring knife casing 141.

In FIGS. 60 a-60 b, another embodiment of attachment ring 22 is formedby molding a polymer to form interface lip 25, cylindrical ring wall 29,distal band 31, and ring seal 34 as a single, unitary structure. Theseparts of attachment ring 22 and cuff 35 function in the manner describedin connection with FIGS. 46 a and 46 b. The molding method and polymermaterials are the same as described in connection with FIGS. 46 a and 46b. The longitudinal height of attachment ring 22 is the axial distanceor dimension, indicated by arrow 348, between the top of interface lip25 and the bottom of cuff 35. The longitudinal height also correspondsto the maximum axial length of ring channel 14 which passes entirelythrough attachment ring 22.

As shown in FIG. 60 a, proximal reinforcement band 202 and distalreinforcement band 204 are embedded within interface lip 25 and distalband 31. Reinforcement bands 202 and 204 are in the shape of rings andcan be embedded by inserting them into a mold before introduction ofpolymer material into the mold. Reinforcement bands 202 and 204 can bepositioned in the mold so that they are completely encased within thepolymer material. Reinforcement 730 is attached to the exterior ofcylindrical ring wall 29 and distal band 31. Reinforcement 730 is ahollow cylindrical structure that includes flange portion 730 a attachedto distal band 31. Reinforcement 730 can be attached by placing it in amold before introduction of the polymer material into the mold.Reinforcement 730 can be positioned in the mold so that one side ofreinforcement 730 becomes bonded to the polymer material upon cooling ofthe polymer material and the opposite side of reinforcement 730 isexposed upon removal from the mold.

Reinforcement 730 can be made of material that is more resistant totearing and puncture than the polymer material which forms cylindricalring wall 29 and distal band 31. During placement of suture 208,reinforcement 730 minimizes the risk of inadvertent puncture ofcylindrical ring wall 209 and minimizes risk of tearing around entrypoints of suture 208.

In some embodiments, reinforcement 730 is embedded within cylindricalring wall 29 and distal band 31.

In some embodiments, reinforcement 730 is made of a fiber mesh with aswas described in connection with FIGS. 46 a and 46 b. The fiber mesh canbe on the outer surface of cylindrical ring wall 29 and distal band 31.Alternatively, the fiber mesh can be entirely embedded withincylindrical ring wall 29 and distal band 31.

Suture 208 secures cuff 35 to distal band 31. Suture 208 is not to beconfused with suture 113 used to secure cuff 35 to the heart. Suture 208repeatedly passes through reinforcement layer 730, distal band 31,distal reinforcement band 204, and cuff 35. Suture 208 passes throughthese parts in a helical manner.

As shown in FIG. 60 b, distal reinforcement band 204 includesthrough-holes 732 arranged circumferentially throughout band 204.Through-holes 732 are spaced apart at regular intervals throughout thecircumference of band 204. Through-holes are sized to accept suture 208and a needle used for placement of suture 208. With through-holes 732,distal reinforcement band 204 can be made of a more rigid material thanwhat would be needed if the needle were required to pierce band 204. Amore rigid material for distal reinforcement band 204 allows for morestructural support of distal band 31.

In the illustrated embodiment, proximal and distal reinforcement bands202 and 204 are the same in all physical respects, such as size, shapeand material. Thus, as shown in FIG. 60 b, proximal reinforcement band202 includes through-holes 732. In other embodiments, proximalreinforcement band 202 does not have any through-holes.

Referring again to FIG. 60 a, the interior surface of cylindrical ringwall 29 includes protrusion 734 that extends radially inward towardlongitudinal axis 200 at the center of ring channel 14. In use, inflowconduit 10 is inserted into ring channel 14 of attachment ring 22.Inflow conduit 10 is prevented from slipping out of ring channel 14 byring clamp 24. Ring clamp 24 compresses cylindrical ring wall 29radially inward, towards the outer surface of inflow conduit 10.Protrusion 734 is axially positioned on cylindrical ring wall 29 at alocation opposite to where ring clamp 24 would be positioned, soprotrusion 734 grabs or frictionally engages the outer surface of inflowconduit 10 when ring clamp is clamped 24 shut. Protrusion 734 is in theform of an annular rib on cylindrical wall 29 and is axially positionedon a central segment of cylindrical ring wall 29. The annular rib is anintegral part of cylindrical wall 29 and is made of the same material ascylindrical wall 29. In a presently preferred embodiment, protrusion 734is axially positioned at or about the midpoint between interface lip 25and distal band 31.

Protrusion 734 advantageously allows for large variations in the outerdiameter of inflow conduit 10. Dimensional variations may be inherentfor some manufacturing processes (for example, sintering) for makinginflow conduit 10. With protrusion 734, it is possible to retain withinring channel 14 an inflow conduit with a diameter that is smaller thanwhat would otherwise be possible without protrusion 734. The height 736of protrusion 734, defined as the radial distance from protrusion peakto base, can be about 0.5 mm to 0.8 mm (about 20 mil to 30 mil), thoughother heights are possible depending on the expected range of sizes forinflow conduit 10 and the compressibility of protrusion 734.

Ring seal 34, interface lip 25, cylindrical wall 29, reinforcement layer730, protrusion 734, distal band 31, reinforcement bands 202 and 204,and cuff 35 are rotationally symmetric about longitudinal axis 200 andextend in a circular manner around longitudinal axis 200.

In the illustrated embodiment, protrusion 734 extends 360 degrees, as acircle, around an inner circumference of cylindrical wall 29.

In some embodiments, the protrusion does not extend as a circle aroundan inner circumference of cylindrical wall 29. The protrusion can beconfigured in a variety of ways so that it engages inflow conduit 10 tominimize or prevent slippage. For example, and without limitation, theprotrusion may extend 180 degrees, as a semi-circle. Alternatively, theprotrusion may extend less than 180 degrees. As a further example, therecan be a plurality of protrusions spaced apart from each other anddistributed around an inner circumference of cylindrical wall 29.

In some embodiments, the attachment ring of FIGS. 60 a-60 b has no ringseal 34. In some embodiments, the attachment ring of FIGS. 60 a-60 bincludes ring valve 230 as described in connection with FIGS. 48 a-48 d.

One or more features of the attachment rings of FIGS. 2 a, 3 a, 4 a, 7a, 8 a, 9 a, 19 a, 20, 25, 26 a, 46 a, and 48 a can be added to formvariations of the attachment ring of FIGS. 60 a-60 b. The attachmentring of FIGS. 60 a-60 b, with and without the above variations, can beused in the same manner as in previously described embodiments of theattachment ring (e.g., FIGS. 2 a, 3 a, 4 a, 7 a, 8 a, 9 a, 19 a, 20, 25,26 a, 46 a, 48 a).

In FIGS. 61 a-61 c, an articulated clamp 24 is shown having hingedlinkages that allow clamp 24 to be easily installed and removed fromattachment ring 22, either before or after attachment ring 22 has beensecured to heart tissue. The linkages are in the form of first curvedpiece 240, second curved piece 242, lever 244, and third curved piece246. When clamp 24 is closed (FIG. 61 a), inner surfaces of first,second and third curved pieces 240, 242, 246 form a circle havingdiameter 247 needed to allow the curved pieces to apply pressure toattachment ring wall 29 in order to secure inflow conduit 10 toattachment ring 22. Diameter 247 can be the same as, about the same as,or slightly smaller (for example, 5%, 10%, or 20% smaller) than theouter diameter of attachment ring wall 29. The linkages can be pivotedrelative to each other so as to create an opening that is larger thatthe outer diameter of attachment ring wall 29. With this ability,attachment ring 22 can be installed and removed from attachment ring 22in a manner that avoids interference from interface lip 25 and cuff 35.

In comparison to the clamp of FIGS. 49 a-49 d, the locations of firstand second lever hinges 248 and 250 are reversed. This causes lever 244to pivot in a different manner. In order to close clamp 24, the free endof lever 244 is moved toward hook 245 in the embodiment of FIGS. 61 a-61c and away from hook 245 in the embodiment of FIGS. 49 a-49 d.

Referring to FIG. 61 b, the ends of first curved piece 240 and secondcurved piece 242 are pivotally connected to each other by primary hinge241. The opposite end of first curved piece 240 has hook 245. Theopposite end of second curved piece 242 is connected by first leverhinge 248 to medial part 252 of lever 244. Second lever hinge 250connects a first end of lever 244 to one end of third curved piece 246.The first end of lever 244 is disposed between two legs 254 of thirdcurved piece 246. Medial part of 252 of lever 244 is disposed betweentwo legs 253 of second curved piece 242. The opposite end of thirdcurved piece 246 has cylindrical catch 256. Cylindrical catch 256 issized and shaped to fit within hook 245.

FIGS. 61 a and 61 d shows clamp 24 when closed. Lever 244 is disposedwithin groove 740 (FIG. 61 b) and between legs 254 of third curved piece246. Cylindrical catch 256 is seated within hook 245. Protrusion 258 atthe free end of lever 244 is positioned near hook 245. First curvedpiece 240 has protrusion 742 adjacent hook 245. To close clamp 24, aperson can stabilize first curved piece 240 by holding onto protrusion742 using a surgical clamp or grasper. Another surgical clamp or graspercan be used to hold onto protrusion 258 at the free end of lever 244 andthereby move lever 244 from its open position (FIGS. 61 b-61 c) to itsclosed position (FIGS. 61 a and 61 d). Use of surgical clamps orgraspers may be needed if there is limited space within a patient'schest cavity.

To open clamp 24, a person can pull protrusion 258 at the free end oflever 244 radially outward in the direction of arrow 262. Movement ofprotrusion 258 in the direction of arrow 262 causes second and thirdcurved pieces 242, 244 to separate from each other and allows innerdiameter 247 to enlarge. Enlargement of inner diameter 247 allowscylindrical catch 256 to be moved in the direction of arrow 260 anddisengage out from hook 245.

Clamp 24 can have features for keeping lever 244 from moving out of theclosed position. Through hole 264 is formed through the free end oflever 244. Through hole 744 is formed through hook 245. When in theclosed position, as shown in FIG. 61 a, a suture (not shown) can belooped through both through holes 264, 744. Opposite ends of the suturecan be tied together in a knot to keep the suture in place. The sutureprevents lever 244 from moving out in the direction of arrow 262 andthereby keeps clamp 24 closed. The suture can later be cut to allow itsremoval and to allow clamp 24 to be opened.

Clamp 24 includes detent features that provide feedback to the user tohelp ensure that clamp 24 is properly closed. When lever 244 is fullyseated within groove 740 (FIG. 61 b), detent features 755 on lever 244engages detent features 746 within groove 740. Detent features 755 and746 can include mating pairs of depressions and bumps that are sized andshaped to provide some mechanical resistance and/or audible soundimmediately before or during engagement. The mechanical resistanceand/or audible sound signals proper engagement to the user. Detentfeatures 746 are disposed on cantilevered members 748 on third curvedpiece 246. Cantilevered members 748 are configured to bend and allowdetent features 746 to snap into engagement with detent features 755 onlever 244.

Clamp 24 includes a snap feature that provides feedback to the user tohelp ensure that clamp 24 is properly closed. When cylindrical catch 256is being moved into hook 245, snap feature 750 on hook 245 provides somemechanical resistance against cylindrical catch 256. Snap feature 750can include a bump that is sized to partially block the path ofcylindrical catch 256 yet still allow cylindrical catch 256 to snap intobase 752 of the hook cavity. The snap action provides a tactile and/oraudible signal to the user that cylindrical catch 256 has entered base752. Thereafter, cylindrical catch 256 is retained in base 752 by snapfeature 750. When pivoting lever 244 is in its open position, innerdiameter 247 is relatively large and would allow the possibility ofcylindrical catch 256 to inadvertently move out of the hook cavity ifsnap feature 750 were not present. Snap feature 750 reduces thepossibility of cylindrical catch 256 from inadvertently moving out ofthe hook cavity during the process of moving pivoting lever 244 to itsclosed position.

In FIGS. 62 a-62 c, an articulated clamp 24 is shown which has all thestructural elements and functionality previously described in FIGS. 61a-61 d with the addition of compliance feature 800. In one embodiment,compliance feature 800 can form an integral part of first curved piece240. That is, compliance feature 800 and first curved piece 240 are aunitary structure. An injection molding process can be performed tofabricate first curve piece 240 with compliance feature 800.Alternatively, a single piece of material can be machined or milled tofabricate first curve piece 240 with compliance feature 800. Suitablematerials from which the compliance feature 800 can be made includewithout limitation, metals and polymers such as thermoplastic resin.

Compliance feature 800 is configured to expand circumferentially in thedirection of arrows 802 in response to tension applied to first curvedpiece 240. As explained below, the circumferential expansion allowsclamp 24 to be used with attachment rings 22 and inflow conduits 10having a wide range of sizes without excessive compression of theattachment ring and without excessive stress at various parts of clamp24. The circumferential expansion provided by compliance feature 800 canalso reduce the amount of force needed to be applied to lever 244 inorder to completely close clamp 24 onto attachment ring 22.

As previously indicated, ring wall 29 of attachment ring 22 can be madeof a resilient and compliant material, such as silicone rubber, thatfrictionally engages the outer surface of inflow conduit 10 which hasbeen inserted through the center of attachment ring 22, as shown forexample in FIG. 9 b. Clamp 24 compresses ring wall 29 against inflowconduit 10 to prevent inflow conduit from inadvertently slipping out ofattachment ring 22. The amount of compression should be limited to allowfor sufficient frictional engagement without damaging ring wall 29.However, the amount of compression usually depends upon the diameter ofattachment ring 22 and the diameter of inflow conduit 10. Variations inthe diameter of attachment ring 22 and the diameter of inflow conduit 10can result in too much or too little compression which can damage ringwall 29 or allow inflow conduit 10 to slip out from attachment ring 22.Dimensional variations may be inherent for some manufacturing processes(for example, sintering) for making inflow conduit 10. Compliancefeature 800 compensates for dimensional variations and thus eliminatesor reduces the possibility of damage to ring wall 29 and slippage ofinflow conduit 10.

With compliance feature 800, it is to be understood that inner diameter247 of clamp 24 can increase from a nominal size (shown in FIG. 62 a) toa greater size to accommodate larger attachment rings 22 and/or largerinflow conduits 10. For example, if the diameter of attachment ring 22and/or inflow conduit 10 is significantly larger than the nominal sizeof diameter 247, compliance feature 800 will circumferentially expandwhen clamp 24 is being locked around attachment ring 22, therebyenlarging diameter 247. Without such expansion, movement of lever 244 toits closed and locked position may be impossible or may be difficult,requiring the user to apply a higher amount of force on lever 244 thatcan result in potentially damaging stress on hinges 241, 248 and 250,hook 245, and/or other parts of clamp 24. Also, without such expansion,even if lever 244 is successfully closed, ring wall 29 of attachmentring 22 might become damaged due to excessive compression.

To allow for expansion, compliance feature 800 is more flexible thansurrounding portions of first curved piece 240. In one embodiment,greater flexibility is provided by an undulating wall having wallthickness 804 which is less than wall thickness 806 of surroundingportions of first curved piece 240. In FIG. 62 a, wall thickness 804 andwall thickness 806 are measured on a plane perpendicular to longitudinalaxis 801 running through the center of clamp 24. The undulating wall isa bellows-like structure having a coiled series of linear segments 808arranged at acute angles relative to each other and connected to eachother by U-shaped curved segments 810 configured to bend and allow theangles between the linear segments to enlarge. That is, compliancemember 800 comprises an alternating series of linear segments 808 andcurved segments 110. Bending of curved segments 110 allows for expansionof the compliance feature 800. Curved segments 110 are resilient in thatthey have a natural tendency to return to their unstressed configuration(shown in FIG. 62 a) after they are bent, thus causing pressure to beapplied to attachment ring 22 after clamp 24 is locked shut. Compliancefeature 800 is configured to autonomously contract after it has beenexpanded in response to applied tension. Compliance feature 800functions as a tension spring or extension spring within first curvedpiece 240.

In the illustrated embodiments, compliance feature 800 comprises tencurved segments 810, though it will be appreciated that any number ofcurved segments can be implemented. In other embodiments, the compliancefeature has one curved segment, two curved segments, three curvedsegments, or greater than three curved segments. In other embodiments,the undulating wall of compliance feature 800 is an alternating seriesof curved segments with essentially no linear segments.

In FIGS. 62 a-62 b, the undulating wall has a sinusoidal wave form withthe amplitude oriented radially from the center of clamp 24. In 62 a-62b, there is one undulating wall. In other embodiments, there are two ormore undulating walls running circumferentially and located side-by-sideto each other. The multiple undulating walls can be located radiallyside-by-side, or they can be stacked longitudinally side-by-side fromtop to bottom of clamp 24. For a “radially side-by-side” example, aninner undulating wall can connect to or intersect inner surface 816 ofclamp 24, and an outer undulating wall can connect to or intersect outersurface 818 of clamp 24. An intermediate undulating wall can be disposedradially between the inner undulating wall and the outer undulatingwall. Optionally, there can be a plurality of connections which connecta limited number of points on one of the undulating walls to a limitednumber of points on another one of the undulating walls.

As shown in FIG. 62 c, the undulating wall may comprise of more or lesscurved segments at an angle 90 degrees from what is illustrated in FIG.62 a. The undulating wall has a sinusoidal wave form with the amplitudeoriented longitudinally (i.e., from top to bottom of clamp 24). In FIG.62 c, there is one undulating wall. In other embodiments, there are twoor more undulating walls running circumferentially and locatedside-by-side to each other. The multiple undulating walls can be locatedradially side-by-side or they can be longitudinally stacked side-by-sidefrom top to bottom of clamp 24. For a “longitudinally stacked” example,a top undulating wall can connect to or intersect top surface 820 ofclamp 24, and a bottom undulating wall can connect to or intersectbottom surface 822 of clamp 24. A middle undulating wall can be disposedlongitudinally between the top undulating wall and the bottom undulatingwall. Optionally, there can be a plurality of connections which connecta limited number of points on one of the undulating walls to a limitednumber of points on another one of the undulating walls.

In FIG. 62 c, the undulating wall has wall thickness 805 which is lessthan wall thickness 807 of surrounding portions of first curved piece240. Wall thickness 805 and wall thickness 807 are measured on planesthat are tangential to outer surface 818 of clamp 24.

In other embodiments, the compliance feature is formed of a materialthat is different from the remainder of the first curved piece 240. Thematerial of the compliance feature can have a greater elasticity orgreater elastic modulus than the material of surrounding portions of thefirst curved piece 240. In such embodiments, the compliance feature caninclude the relatively thin undulating wall described in connection withFIG. 62 a or the compliance feature can have the same wall thickness assurrounding portions of the first curved piece 240.

In other embodiments, the compliance feature is located on second curvedpiece 242 or on third curved piece 246. In further embodiments, multiplecompliance features are located on one or a combination of first curvedpiece 240, second curved piece 242, and third curved piece 246.

In some embodiments, the compliance feature is configured with avariation in diameter. For example, the compliance feature can allow forabout a 5% increase in diameter 247, about a 10% increase in diameter247, or about a 15% increase in diameter 247 while lever 244 is in itsclosed and locked position (FIG. 62 a).

In other embodiments, the compliance feature and the curved piece onwhich it is located are not a unitary structure. For example, thecompliance feature can be fabricated separately from the curved pieceand then added to the curved piece. As a further example, first curvedpiece 240 can be fabricated in two halves and the compliance feature canbe added, by bonding or mechanical attachment, to connect the two havestogether.

In summary, the compliance feature can be implemented in other waysknown to one with ordinary skilled in the art with the object ofaccomplishing the function of introducing compliance to clamp 24 toaccommodate for securing clamp 24 over attachment ring 22 having aslightly larger outer diameter than the nominal inner diameter of clamp24.

FIG. 63 a-63 c shows needle guard 760 configured for temporary insertioninto ring channel 14 of any attachment ring 22 described above during asurgical procedure. Needle guard 760 has bottom end surface 762 and sidesurface 764. Needle guard 760 is inserted so that its bottom end surface762 abuts the outer surface of heart 106. Bottom end surface 762 isconcave or cup-shaped, thereby forming a small depression at the bottomend of needle guard 760. Side surface 764 is a cylindrical surfacehaving an outer diameter that is the same or about the same as thediameter of ring channel 14 or the inner diameter of cylindrical ringwall 29. Side surface 764 has an axial length that is sufficient toallow side surface 764 to extend entirely through ring channel 14.Needle guard 760 is made of a rigid, biocompatible material, includingconventional metals and polymers used for surgical instruments. Thematerial used provides bottom end surface 760 and side surface 760 withsufficient hardness to prevent significant penetration by needles usedfor suturing. In a presently preferred embodiment, bottom end surface760 and side surface 760 are non-porous and smooth.

As described above, attachment ring 22 is optionally secured to heart106 by suture 113 which passes through heart tissue and cuff 35 ofattachment ring 22. Suture 113 is not to be confused with suture 208used to secure cuff 35 to cylindrical ring wall 29 of attachment ring22. The lead end of suture 113 is typically attached to sharp needle 112which is manipulated by a surgeon. A first loop of suture 113 is formedas follows. Needle 112 pierces the outer surface of heart 106 at a pointlocated radially outward from cuff 35, and pulls suture 113 downwardinto the heart wall. Next, needle 112 curves upward to pierce the outersurface of heart 106 at a point located directly beneath cuff 35. Needle112 continues upward, piercing through cuff 35 and pulling suture 113through and out of cuff 35. Thereafter, a second loop of suture 113 isformed by shifting needle to another position so that is pierces theother surface of heart 106 at another point located radially outwardfrom cuff 35. The steps for forming the first loop are repeated, so thatsuture 113 is pulled up through another location on cuff 35. Any numberof loops, as desired by the surgeon, are formed in a helical manner tosecure cuff 35 to heart 106 at multiple points.

As shown in FIG. 63 c, in the event that needle 112 curves upward toexit the heart wall at a point located radially inward of cuff 35,needle 112 will abut bottom end surface 762 of needle guard 760. Needleguard 760 will block needle 112 from continuing upward into ring channel14 of attaching ring 22. If needle 112 were to continue upward into ringchannel 14 (in the absence of needle guard 760), it might puncture ortear cylindrical ring wall 29 and possibly allow blood to leak out at alater time.

After the desired number of suture loops are formed, needle guard 760 ispulled completely out of ring channel 14 of attachment ring 22.Thereafter, a hole is cored through the heart wall at a locationdirectly below ring channel 14 to allow for installation of inflowconduit 10 using any of the methods described above. The hole throughthe heart wall can be made according to any of the methods describedabove. For example, the hole can be made using coring knife 140. As afurther example, inflow conduit 10 can be secured to attachment ring 22with ring clamp 24.

As shown in FIGS. 64 a-64 b, the above suturing procedure can also beperformed after a hole has been cored through the heart wall. The holethrough the heart wall can be made according to any of the methodsdescribed above. After a hole has been cored through the heart wall,needle guard 760 is inserted into the ring channel 14 of attachment ring22 so that bottom end surface 762 of needle guard 760 is located belowcuff 35 and below the outer surface of heart 106. Optionally, as shownin FIG. 64 b, bottom end surface 762 is located inside the heart cavity.When needle guard 760 is in its desired and final position, suture 113can be looped through cuff 35 according to the procedure described abovein connection with FIGS. 63 a-63 b. In the event that needle 112 curvestoward the center of the ring channel 14, needle 112 will abut bottomend surface 762 or side surface 764 of needle guard 760 and therebyprevent needle 112 from possibly damaging cylindrical ring wall 29 ofattachment ring 22.

After the desired number of suture loops are formed, needle guard 760 ispulled completely out of the hole in the heart wall and ring channel 14of attachment ring 22. Thereafter, inflow conduit 10 can be insertedinto ring channel 14 and the hole in the heart wall, then secured toattachment ring 22 with ring clamp 24.

FIG. 65 shows another embodiment of needle guard 760. Cylinder 766 isconfigured to pass into ring channel 14 of attachment ring 22. Cylinder766 has a maximum outer diameter 768 that is the same or about the sameas the diameter of ring channel 14 or the inner diameter of cylindricalring wall 29. Stop member 770 is attached to the top of cylinder 766 andhas an outer diameter 772 that is greater than the diameter of ringchannel 14 and the inner diameter of cylindrical ring wall 29. Outerdiameter 772 corresponds to the maximum width of stop member 770. Stopmember 770 is sized and shaped to abut interface lip 25 of attachmentring 22 and thereby limit the extent to which cylinder 766 moves intoring channel 14. Stop member 770 is disposed between handle 774 andcylinder 766. Handle 774 includes stem 776 and pull member 778 which iswider than stem 776. Stem 776 and pull member 778 are sized and shapedto allow for manipulation with fingers or surgical instruments. Forexample, the axial length of stem 776 can be of sufficient size to allowa person's finger to fit between pull member 778 and stop member 770.

Outer side surface 764 of cylinder 776 includes two circumferentialgrooves which can provide an indexing function in relation to attachmentring 22, as described below. First groove 780 is located at first axialdistance 782 from bottom tip 784 of needle guard 760. Second groove 784is located immediately below stop member 770 and at second axialdistance 786 from bottom tip 784. Both grooves 780 and 786 encirclecylinder 766. Both grooves 780 and 786 can be configured to engage afeature of attachment ring 22 which protrudes radially inward fromcylindrical ring wall 29 and into ring channel 14. For example, eitherone or both grooves 780 and 786 can be configured to receive ring seal34 of attachment ring 22, so that ring seal 34 becomes seated within oneof the grooves as needle guard 760 is inserted into attachment ring 22.In cases where attachment ring 22 has no ring seal 34, either one orboth grooves 780 and 786 can be configured to receive protrusion 734(FIG. 60 a) or some other protruding feature of attaching ring 22. In apresently preferred embodiment, both grooves 780 and 786 extendcircumferentially and completely around cylinder 766. In alternativeembodiments, one or both grooves 780 and 786 extend circumferentiallybut only partially around cylinder 766.

In one embodiment, first axial distance 782 can be the same or about thesame as the longitudinal height 348 of attachment ring 22. Thisdimensional relationship can help prevent attachment ring 22 frominadvertently working its way up needle guard 760 and thereby cause cuff35 of attachment ring 22 to lift off the outer surface of heart 106.Cuff 35 preferably remains in contact with the outer surface of heart106 during the suturing process. This dimensional relationship betweenfirst axial distance 782 and longitudinal height 348 can also helpensure that needle guard 788 does not inadvertently lift out ofattachment ring 22 when suture 113 is being placed through cuff 35 ofattachment ring 22. This dimensional relationship can also provide atactile signal to the user when attachment ring 22 enters first groove780. The tactile signal would indicate that bottom tip 784 of needleguard 760 has reached the outer surface of heart 106, thereby allowingthe surgeon to avoid pressing needle guard 760 onto heart 106 during theprocedure described in connection with FIGS. 63 a-63 c.

Referring again to FIG. 65, second axial distance 788 defines thelocation of second groove 786 and stop member 770. In one embodiment,second axial distance 786 can be the same or about the same aslongitudinal height 348 of attachment ring 22 (first axial distance 782being less than longitudinal height 348), so that second groove 786functions in the same way as first groove 780 in the previous paragraph.In another embodiment, second axial distance 788 is greater thanlongitudinal height 348 of attachment ring 22 so that, during theprocedure described for FIGS. 64 a-64 b, a tactile signal to the user isprovided when bottom tip 784 of needle guard 760 has reached a pointbeyond cuff 35 and below the outer surface of heart 106. During theprocedure described for FIGS. 64 a-64 b, second groove 786 can also helpprevent needle guard 788 from inadvertently lifting up from attachmentring 22 when suture 113 is being placed through cuff 35 of attachmentring 22.

Any elements described herein as singular can be pluralized (i.e.,anything described as “one” can be more than one). Attaching, coupling,and joining can be used interchangeably within this description. Anyspecies element of a genus element can have the characteristics orelements of any other species element of that genus. The above-describedconfigurations, elements or complete assemblies and methods and theirelements for carrying out the invention, and variations of aspects ofthe invention can be combined and modified with each other in anycombination.

1. A needle guard for use with a cardiac attachment ring of a heartassist system, the needle guard comprising: a cylinder including a topend, a bottom end surface, and cylindrical side surface defining anouter diameter; and a stop member at the top end of the cylinder, thestop member having a maximum width greater than the outer diameter ofthe cylindrical side surface.
 2. The needle guard of claim 1, furthercomprising a handle at the top end of cylinder.
 3. The needle guard ofclaim 2, wherein the handle comprises a stem and a pull member widerthan the stem, the stem disposed between the pull member and thecylinder.
 4. The needle guard of claim 1, wherein the cylindrical sidesurface includes a first groove that extends circumferentially aroundthe cylinder.
 5. The needle guard of claim 4, wherein the cylindricalside surface includes a second groove that extends circumferentiallyaround the cylinder, the first groove located axially between the secondgroove and the bottom end surface.
 6. The needle guard of claim 5,wherein the second groove is adjacent the stop member.
 7. An assemblyfor attaching a heart assist device to the heart, the assemblycomprising: an attachment ring having a ring channel extending throughthe attachment ring, the attachment ring including a cylindrical ringwall and a cuff extending radially outward from the cylindrical ringwall, the cylindrical ring wall extending circumferentially around thering channel; and a needle guard including a cylinder shaped and sizedto pass through the ring channel.
 8. The assembly of claim 7, whereinthe cylinder has a maximum outer diameter that is the same or about thesame as an inner diameter of the cylindrical ring wall.
 9. The assemblyof claim 7, wherein an axial length of the cylinder is the same or aboutthe same as a maximum axial length of the ring channel.
 10. The assemblyof claim 7, wherein an axial length of the cylinder is greater than amaximum axial length of the ring channel.
 11. The assembly of claim 7,wherein the cylindrical ring wall includes a protrusion that extendsradially inward into the ring channel, the protrusion located on acentral segment of the cylindrical ring wall.
 12. The assembly of claim7, wherein the cylinder of the needle guard includes a groove thatextends circumferentially around the cylinder.
 13. The assembly of claim12, wherein the attachment ring includes a ring seal configured toengage the groove.
 14. The assembly of claim 12, wherein the cylinder ofthe needle guard includes another groove that extends circumferentiallyaround the cylinder.
 15. A method of attaching an attachment ring of aheart assist system to the heart, the method comprising: inserting aneedle guard into an attachment ring; and inserting a suture throughheart tissue and a cuff of the attachment ring while the needle guard istemporarily disposed within the attachment ring, the suture connectingthe attachment ring to the heart tissue.
 16. The method of claim 15,wherein the inserting of the needle guard includes abutting a stopmember of the needle guard against a top end of the attachment ring. 17.The method of claim 15, wherein the inserting of the needle guardincludes aligning a groove on a cylindrical side surface of the needleguard with a ring seal of the attachment ring.
 18. The method of claim15, wherein the inserting of the suture is performed while a bottom tipof the needle guard is located below an outer surface of the hearttissue.
 19. The method of claim 15, further comprising removing theneedle guard out of the attachment ring after the inserting of thesuture.
 20. The method of claim 15, wherein the inserting of the sutureincludes: passing a needle into the heart tissue at a point locatedradially outward from the cuff, the needle connected to the suture;followed by passing the needle out from the heart tissue at a pointlocated directly beneath the cuff; followed by passing the needle upthrough the cuff so that the suture is pulled through the heart tissueand the cuff.
 21. A ring clamp for securing an inflow conduit to anattachment ring, the ring clamp comprising: a first curved pieceincluding a first end, a second end, and a first engagement member atthe second end; a second curved piece including a first end and a secondend, the first end of the second curved piece pivotally connected to thefirst end of the first curved piece; a third curved piece including afirst end, a second end, and a second engagement member at the secondend, the second engagement member configured to selectively engage anddisengage the first engagement member; and a lever including a firstlever end, a second lever end, and a medial segment, the first lever endpivotally connected to the first end of the third curved piece, themedial segment pivotally connected to the second end of the secondcurved piece.
 22. The ring clamp of claim 21, wherein the firstengagement member is a hook and the second engagement member is a catch.23. The ring clamp of claim 21, wherein the first curved piece, thesecond curved piece, or the third curved piece includes a compliancefeature configured to circumferentially expand under tension andautonomously contract after expansion.
 24. The ring clamp of claim 23,wherein the compliance feature includes a series of curved segmentsconfigured to bend when tension is applied to opposite ends of thecompliance feature.
 25. The ring clamp of claim 23, wherein thecompliance feature includes an undulating wall having a wall thicknessless than that of adjacent portions of the curved piece including thecompliance feature.
 26. The ring clamp of claim 23, wherein thecompliance feature is formed of a material having an elasticity thatdiffers from the material of adjacent portions of the curved pieceincluding the compliance feature.
 27. The ring clamp of claim 21,wherein the third curved piece includes a groove.
 28. The ring clamp ofclaim 27, wherein the lever fits within the groove.
 29. The ring clampof claim 27, wherein the ring clamp has a closed orientation in whichthe lever is disposed in the groove, the second engagement member isengaged to the first engagement member, and the first curved piece, thesecond curved piece, and the third curved piece complete a circular ringhaving an inner diameter.
 30. The ring clamp of claim 21, wherein thering clamp has a closed orientation in which the second lever end isdisposed adjacent the first engagement member, the second engagementmember is engaged to the first engagement member, and the first curvedpiece, the second curved piece, and the third curved piece complete acircular ring having an inner diameter.
 31. The ring clamp of claim 21,wherein the second curved piece includes two leg members attached to themedial segment of the lever, and the lever is sized to fit between thetwo leg members.
 32. The ring clamp of claim 21, wherein the lever andthe third curved piece include detent features configured to engagedeach other.
 33. The ring clamp of claim 32, wherein at least one of thedetent features is disposed on a cantilevered member on the third curvedpiece.
 34. A ring clamp for securing an inflow conduit to an attachmentring, the ring clamp comprising: a lever; and a plurality of curvedpieces, the lever and the curved pieces pivotally connected to eachother, at least one of the curve pieces including a compliance featureconfigured to expand under tension and autonomously contract afterexpansion, wherein the lever is pivotally attached to two of the curvedpieces, the plurality of curved pieces includes a first curved piece, asecond curved piece, and a third curved piece, and wherein the firstcurved piece is configured to selectively engage and disengage the thirdcurved piece.
 35. The ring clamp of claim 34, wherein the lever ispivotally attached to the second curved piece and to the third curvedpiece.
 36. The ring clamp of claim 34, wherein the third curved pieceincludes a groove configured to receive the lever.
 37. The ring clamp ofclaim 34, wherein the compliance feature includes a series of curvedsegments configured to bend when tension is applied to opposite ends ofthe compliance feature.
 38. The ring clamp of claim 34, wherein thecompliance feature includes an undulating wall having a wall thicknessless than that of adjacent portions of the curved piece including thecompliance feature.
 39. The ring clamp of claim 34, wherein thecompliance feature is formed of a material having an elasticity thatdiffers from the material of adjacent portions of the curved pieceincluding the compliance feature.